Clinical Trial Results:
Empagliflozin as a Modulator of Systemic Vascular Resistance and Cardiac Output in Patients with Type 2 Diabetes
Summary
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EudraCT number |
2016-000172-19 |
Trial protocol |
DE |
Global end of trial date |
23 Jan 2019
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Results information
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Results version number |
v1(current) |
This version publication date |
30 Oct 2021
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First version publication date |
30 Oct 2021
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
15-124
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT03132181 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
RWTH Aachen University for the Medical Faculty, represented by Center for Translational & Clinical Research Aachen (CTC-A)
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Sponsor organisation address |
Pauwelsstraße 30, Aachen, Germany, 52074
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Public contact |
Center for Translational & Clinical Research Aachen (CTC-A), RWTH Aachen University, +49 2418080092, ctc-a-sekretariat@ukaachen.de
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Scientific contact |
Center for Translational & Clinical Research Aachen (CTC-A), RWTH Aachen University, +49 2418080092, ctc-a-sekretariat@ukaachen.de
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
29 May 2020
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
23 Jan 2019
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Global end of trial reached? |
Yes
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Global end of trial date |
23 Jan 2019
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
Effect of empagliflozin 10 mg once daily on cardiac output in comparison to placebo after 1 day, 3 days and 12 weeks of treatment (measured with a noninvasive monitoring [ClearSight System]).
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Protection of trial subjects |
This study was conducted in accordance with International Conference on Harmonisation of Good Clinical Practice, the principles of the Declaration of Helsinki, as well as other applicable local ethical and legal requirements.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
02 May 2017
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Germany: 44
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Worldwide total number of subjects |
44
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EEA total number of subjects |
44
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
27
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From 65 to 84 years |
17
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85 years and over |
0
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Recruitment
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Recruitment details |
Recruitment and treatment of subjects was performed in one trial center. Overall 44 subjects were enrolled and randomized in the clinical trial in the timeframe from 02.05.2017 till 22.10.2018. | |||||||||||||||
Pre-assignment
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Screening details |
Overall 55 subjects were screened in one trial center. Of those 55 subjects screened, 44 subjects met the inclusion and exclusion criteria and were enrolled and randomized in the clinical trial. | |||||||||||||||
Period 1
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Period 1 title |
Baseline visit
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Is this the baseline period? |
Yes | |||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||||||||
Roles blinded |
Subject, Investigator | |||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Empagliflozin | |||||||||||||||
Arm description |
Subjects in the Empagliflozin arm receive 10 mg tablets Empagliflozin once daily for 3 months. | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
Empagliflozin
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
10 mg tablets once daily administered orally
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Arm title
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Placebo | |||||||||||||||
Arm description |
Subjects in the Placebo arm receive one tablet once daily for 3 months. | |||||||||||||||
Arm type |
Placebo | |||||||||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
One tablet daily administered orally
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Period 2
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Period 2 title |
Day 1
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Is this the baseline period? |
No | |||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||||||||
Roles blinded |
Subject, Investigator | |||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Empagliflozin | |||||||||||||||
Arm description |
Subjects in the Empagliflozin arm receive 10 mg tablets Empagliflozin once daily for 3 months. | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
Empagliflozin
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
10 mg tablets once daily administered orally
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Arm title
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Placebo | |||||||||||||||
Arm description |
Subjects in the Placebo arm receive one tablet once daily for 3 months. | |||||||||||||||
Arm type |
Placebo | |||||||||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
One tablet daily administered orally
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Period 3
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Period 3 title |
Day 3
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Is this the baseline period? |
No | |||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||||||||
Roles blinded |
Investigator, Subject | |||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Empagliflozin | |||||||||||||||
Arm description |
Subjects in the Empagliflozin arm receive 10 mg tablets Empagliflozin once daily for 3 months. | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
Empagliflozin
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
10 mg tablets once daily administered orally
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Arm title
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Placebo | |||||||||||||||
Arm description |
Subjects in the Placebo arm receive one tablet once daily for 3 months. | |||||||||||||||
Arm type |
Placebo | |||||||||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
One tablet daily administered orally
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Period 4
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Period 4 title |
3 Months
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Is this the baseline period? |
No | |||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||||||||
Roles blinded |
Subject, Investigator | |||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Empagliflozin | |||||||||||||||
Arm description |
Subjects in the Empagliflozin arm receive 10 mg tablets Empagliflozin once daily for 3 months. | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
Empagliflozin
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Investigational medicinal product code |
||||||||||||||||
Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
10 mg tablets once daily administered orally
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Arm title
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Placebo | |||||||||||||||
Arm description |
Subjects in the Placebo arm receive one tablet once daily for 3 months. | |||||||||||||||
Arm type |
Placebo | |||||||||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
One tablet daily administered orally
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Baseline characteristics reporting groups
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Reporting group title |
Empagliflozin
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Reporting group description |
Subjects in the Empagliflozin arm receive 10 mg tablets Empagliflozin once daily for 3 months. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
Subjects in the Placebo arm receive one tablet once daily for 3 months. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Empagliflozin
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Reporting group description |
Subjects in the Empagliflozin arm receive 10 mg tablets Empagliflozin once daily for 3 months. | ||
Reporting group title |
Placebo
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Reporting group description |
Subjects in the Placebo arm receive one tablet once daily for 3 months. | ||
Reporting group title |
Empagliflozin
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Reporting group description |
Subjects in the Empagliflozin arm receive 10 mg tablets Empagliflozin once daily for 3 months. | ||
Reporting group title |
Placebo
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Reporting group description |
Subjects in the Placebo arm receive one tablet once daily for 3 months. | ||
Reporting group title |
Empagliflozin
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Reporting group description |
Subjects in the Empagliflozin arm receive 10 mg tablets Empagliflozin once daily for 3 months. | ||
Reporting group title |
Placebo
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Reporting group description |
Subjects in the Placebo arm receive one tablet once daily for 3 months. | ||
Reporting group title |
Empagliflozin
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Reporting group description |
Subjects in the Empagliflozin arm receive 10 mg tablets Empagliflozin once daily for 3 months. | ||
Reporting group title |
Placebo
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Reporting group description |
Subjects in the Placebo arm receive one tablet once daily for 3 months. |
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End point title |
Systemic vascular resistance index - Baseline | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Baseline
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Notes [1] - 2 subjects were retrospectively excluded from analysis due to protocol deviations |
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Statistical analysis title |
Analysis SVRI - Baseline | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
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Number of subjects included in analysis |
42
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.967 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
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End point title |
Systemic vascular resistance index - Day 1 | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Day 1
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Notes [2] - 2 subjects were retrospectively excluded from analysis due to protocol deviations |
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Statistical analysis title |
Analysis SVRI - Day 1 | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
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Number of subjects included in analysis |
42
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.411 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
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End point title |
Systemic vascular resistance index - Day 3 | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Day 3
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Notes [3] - 2 subjects were retrospectively excluded from analysis due to protocol deviations; 1 missing data |
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Statistical analysis title |
Analysis SVRI - Day 3 | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
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Number of subjects included in analysis |
41
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.991 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
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End point title |
Systemic vascular resistance index - 3 Months | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
3 Months
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Notes [4] - 2 subjects were retrospectively excluded from analysis due to protocol deviations; 3 missing data |
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Statistical analysis title |
Analysis SVRI - 3 Months | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
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Number of subjects included in analysis |
39
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.795 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
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End point title |
Cardiac index - Baseline | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Baseline
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Notes [5] - 2 subjects were retrospectively excluded from analysis due to protocol deviations |
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Statistical analysis title |
Analysis CI - Baseline | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
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Number of subjects included in analysis |
42
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.682 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
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End point title |
Cardiac index - Day 1 | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Day 1
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Notes [6] - 2 subjects were retrospectively excluded from analysis due to protocol deviations |
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Statistical analysis title |
Analysis CI - Day 1 | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
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Number of subjects included in analysis |
42
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.771 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
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End point title |
Cardiac index - Day 3 | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Day 3
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Notes [7] - 2 subjects were retrospectively excluded from analysis due to protocol deviations; 1 missing data |
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Statistical analysis title |
Analysis CI - Day 3 | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
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Number of subjects included in analysis |
41
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.293 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
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End point title |
Cardiac index - 3 Months | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
3 Months
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Notes [8] - 2 subjects were retrospectively excluded from analysis due to protocol deviations; 3 missing data |
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Statistical analysis title |
Analysis CI - 3 Months | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
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Number of subjects included in analysis |
39
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.303 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
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End point title |
Heart rate - Baseline | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Baseline
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Notes [9] - 2 subjects were retrospectively excluded from analysis due to protocol deviations |
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Statistical analysis title |
Analysis HR - Baseline | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
42
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.665 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Heart rate - Day 1 | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Day 1
|
||||||||||||
|
|||||||||||||
Notes [10] - 2 subjects were retrospectively excluded from analysis due to protocol deviations |
|||||||||||||
Statistical analysis title |
Analysis HR - Day 1 | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
42
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.122 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Heart rate - Day 3 | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Day 3
|
||||||||||||
|
|||||||||||||
Notes [11] - 2 subjects were retrospectively excluded from analysis due to protocol deviations; 1 missing data |
|||||||||||||
Statistical analysis title |
Analysis HR - Day 3 | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
41
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.717 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Heart rate - 3 Months | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
3 Months
|
||||||||||||
|
|||||||||||||
Notes [12] - 2 subjects were retrospectively excluded from analysis due to protocol deviations; 3 missing data |
|||||||||||||
Statistical analysis title |
Analysis HR - 3 Months | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
39
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.393 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Systolic blood pressure - Baseline | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Baseline
|
||||||||||||
|
|||||||||||||
Notes [13] - 2 subjects were retrospectively excluded from analysis due to protocol deviations |
|||||||||||||
Statistical analysis title |
Analysis syst. BP - Baseline | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
42
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.934 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Systolic blood pressure - Day 1 | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Day 1
|
||||||||||||
|
|||||||||||||
Notes [14] - 2 subjects were retrospectively excluded from analysis due to protocol deviations |
|||||||||||||
Statistical analysis title |
Analysis syst. BP - Day 1 | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
42
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.279 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Systolic blood pressure - Day 3 | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Day 3
|
||||||||||||
|
|||||||||||||
Notes [15] - 2 subjects were retrospectively excluded from analysis due to protocol deviations; 1 missing data |
|||||||||||||
Statistical analysis title |
Analysis syst. BP - Day 3 | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
41
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.115 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Systolic blood pressure - 3 Months | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
3 Months
|
||||||||||||
|
|||||||||||||
Notes [16] - 2 subjects were retrospectively excluded from analysis due to protocol deviations; 4 missing data |
|||||||||||||
Statistical analysis title |
Analysis syst. BP - 3 Months | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
38
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.318 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Diastolic blood pressure - Baseline | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Baseline
|
||||||||||||
|
|||||||||||||
Notes [17] - 2 subjects were retrospectively excluded from analysis due to protocol deviations |
|||||||||||||
Statistical analysis title |
Analysis diast. BP - Baseline | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
42
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.964 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Diastolic blood pressure - Day 1 | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Day 1
|
||||||||||||
|
|||||||||||||
Notes [18] - 2 subjects were retrospectively excluded from analysis due to protocol deviations |
|||||||||||||
Statistical analysis title |
Analysis diast. BP - Day 1 | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
42
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.876 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Diastolic blood pressure - Day 3 | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Day 3
|
||||||||||||
|
|||||||||||||
Notes [19] - 2 subjects were retrospectively excluded from analysis due to protocol deviations; 1 missing data |
|||||||||||||
Statistical analysis title |
Analysis diast. BP - Day 3 | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
41
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.925 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Diastolic blood pressure - 3 Months | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
3 Months
|
||||||||||||
|
|||||||||||||
Notes [20] - 2 subjects were retrospectively excluded from analysis due to protocol deviations; 4 missing data |
|||||||||||||
Statistical analysis title |
Analysis diast. BP - 3 Months | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
38
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.197 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Stroke volume index - Baseline | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Baseline
|
||||||||||||
|
|||||||||||||
Notes [21] - 2 subjects were retrospectively excluded from analysis due to protocol deviations |
|||||||||||||
Statistical analysis title |
Analysis SVI - Baseline | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
42
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.266 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Stroke volume index - Day 1 | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Day 1
|
||||||||||||
|
|||||||||||||
Notes [22] - 2 subjects were retrospectively excluded from analysis due to protocol deviations |
|||||||||||||
Statistical analysis title |
Analysis SVI - Day 1 | ||||||||||||
Comparison groups |
Placebo v Empagliflozin
|
||||||||||||
Number of subjects included in analysis |
42
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.344 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Stroke volume index - Day 3 | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Day 3
|
||||||||||||
|
|||||||||||||
Notes [23] - 2 subjects were retrospectively excluded from analysis due to protocol deviations; 1 missing data |
|||||||||||||
Statistical analysis title |
Analysis SVI - Day 3 | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
41
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.131 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Stroke volume index - 3 Months | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
3 Months
|
||||||||||||
|
|||||||||||||
Notes [24] - 2 subjects were retrospectively excluded from analysis due to protocol deviations; 3 missing data |
|||||||||||||
Statistical analysis title |
Analysis SVI - 3 Months | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
39
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.879 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Left ventricular ejection fraction - Baseline | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Baseline
|
||||||||||||
|
|||||||||||||
Notes [25] - 2 subjects were retrospectively excluded from analysis due to protocol deviations; 2 missing data |
|||||||||||||
Statistical analysis title |
Analysis LV-EF - Baseline | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
40
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.183 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Left ventricular ejection fraction - Day 1 | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Day 1
|
||||||||||||
|
|||||||||||||
Notes [26] - 2 subjects were retrospectively excluded from analysis due to protocol deviations; 2 missing data |
|||||||||||||
Statistical analysis title |
Analysis LV-EF - Day 1 | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
40
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.852 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Left ventricular ejection fraction - Day 3 | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Day 3
|
||||||||||||
|
|||||||||||||
Notes [27] - 2 subjects were retrospectively excluded from analysis due to protocol deviations; 2 missing data |
|||||||||||||
Statistical analysis title |
Analysis LV-EF - Day 3 | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
40
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.333 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Left ventricular ejection fraction - 3 Months | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
3 Months
|
||||||||||||
|
|||||||||||||
Notes [28] - 2 subjects were retrospectively excluded from analysis due to protocol deviations; 2 missing data |
|||||||||||||
Statistical analysis title |
Analysis LV-EF - 3 Months | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
40
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.375 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Left ventricular diastolic function (E/é mean) - Baseline | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Baseline
|
||||||||||||
|
|||||||||||||
Notes [29] - 2 subjects were retrospectively excluded from analysis due to protocol deviations [30] - 1 missing data |
|||||||||||||
Statistical analysis title |
Analysis E/é mean - Baseline | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
41
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.898 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Left ventricular diastolic function (E/é mean) - Day 1 | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Day 1
|
||||||||||||
|
|||||||||||||
Notes [31] - 2 subjects were retrospectively excluded from analysis due to protocol deviations; 1 missing data |
|||||||||||||
Statistical analysis title |
Analysis E/é mean - Day 1 | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
41
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.005 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Left ventricular diastolic function (E/é mean) - Day 3 | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Day 3
|
||||||||||||
|
|||||||||||||
Notes [32] - 2 subjects were retrospectively excluded from analysis due to protocol deviations; 2 missing data |
|||||||||||||
Statistical analysis title |
Analysis E/é mean - Day 3 | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
40
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.079 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Left ventricular diastolic function (E/é mean) - 3 Months | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
3 Months
|
||||||||||||
|
|||||||||||||
Notes [33] - 2 subjects were retrospectively excluded from analysis due to protocol deviations; 3 missing data |
|||||||||||||
Statistical analysis title |
Analysis E/é mean - 3 Months | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
39
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.004 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Left atrial volume index - Baseline | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Baseline
|
||||||||||||
|
|||||||||||||
Notes [34] - 2 subjects were retrospectively excluded from analysis due to protocol deviations; 2 missing data |
|||||||||||||
Statistical analysis title |
Analysis LA VI - Baseline | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
40
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.414 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Left atrial volume index - Day 1 | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Day 1
|
||||||||||||
|
|||||||||||||
Notes [35] - 2 subjects were retrospectively excluded from analysis due to protocol deviations; 2 missing data |
|||||||||||||
Statistical analysis title |
Analysis LA VI - Day 1 | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
40
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.3 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Left atrial volume index - Day 3 | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Day 3
|
||||||||||||
|
|||||||||||||
Notes [36] - 2 subjects were retrospectively excluded from analysis due to protocol deviations; 2 missing data |
|||||||||||||
Statistical analysis title |
Analysis LA VI - Day 3 | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
40
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.84 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Left atrial volume index - 3 Months | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
3 Months
|
||||||||||||
|
|||||||||||||
Notes [37] - 2 subjects were retrospectively excluded from analysis due to protocol deviations; 2 missing data |
|||||||||||||
Statistical analysis title |
Analysis LA VI - 3 Months | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
40
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.239 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Mitral E-wave velocity - Baseline | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Baseline
|
||||||||||||
|
|||||||||||||
Notes [38] - 2 subjects were retrospectively excluded from analysis due to protocol deviations [39] - 1 missing data |
|||||||||||||
Statistical analysis title |
Analysis E - Baseline | ||||||||||||
Comparison groups |
Placebo v Empagliflozin
|
||||||||||||
Number of subjects included in analysis |
41
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.686 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Mitral E-wave velocity - Day 1 | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Day 1
|
||||||||||||
|
|||||||||||||
Notes [40] - 2 subjects were retrospectively excluded from analysis due to protocol deviations; 1 missing data |
|||||||||||||
Statistical analysis title |
Analysis E - Day 1 | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
41
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.003 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Mitral E-wave velocity - Day 3 | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Day 3
|
||||||||||||
|
|||||||||||||
Notes [41] - 2 subjects were retrospectively excluded from analysis due to protocol deviations; 2 missing data |
|||||||||||||
Statistical analysis title |
Analysis E - Day 3 | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
40
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.005 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Mitral E-wave velocity - 3 Months | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
3 Months
|
||||||||||||
|
|||||||||||||
Notes [42] - 2 subjects were retrospectively excluded from analysis due to protocol deviations; 3 missing data |
|||||||||||||
Statistical analysis title |
Analysis E - 3 Months | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
39
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.001 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Glucose serum level - Baseline | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Baseline
|
||||||||||||
|
|||||||||||||
Notes [43] - 2 subjects were retrospectively excluded from analysis due to protocol deviations |
|||||||||||||
Statistical analysis title |
Analysis Glucose - Baseline | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
42
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.742 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Glucose serum level - Day 1 | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Day 1
|
||||||||||||
|
|||||||||||||
Notes [44] - 2 subjects were retrospectively excluded from analysis due to protocol deviations |
|||||||||||||
Statistical analysis title |
Analysis Glucose - Day 1 | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
42
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.049 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Glucose serum level - Day 3 | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Day 3
|
||||||||||||
|
|||||||||||||
Notes [45] - 2 subjects were retrospectively excluded from analysis due to protocol deviations; 1 missing data |
|||||||||||||
Statistical analysis title |
Analysis Glucose - Day 3 | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
41
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.037 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Glucose serum level - 3 Months | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
3 Months
|
||||||||||||
|
|||||||||||||
Notes [46] - 2 subjects were retrospectively excluded from analysis due to protocol deviations; 2 missing data |
|||||||||||||
Statistical analysis title |
Analysis Glucose - 3 Months | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
40
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.754 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
HbA1c serum level - Baseline | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Baseline
|
||||||||||||
|
|||||||||||||
Notes [47] - 2 subjects were retrospectively excluded from analysis due to protocol deviations |
|||||||||||||
Statistical analysis title |
Analysis HbA1c - Baseline | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
42
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.228 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
HbA1c serum leven - Day 1 | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Day 1
|
||||||||||||
|
|||||||||||||
Notes [48] - 2 subjects were retrospectively excluded from analysis due to protocol deviations |
|||||||||||||
Statistical analysis title |
Analysis HbA1c - Day 1 | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
42
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.722 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
HbA1c serum level - Day 3 | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Day 3
|
||||||||||||
|
|||||||||||||
Notes [49] - 2 subjects were retrospectively excluded from analysis due to protocol deviations; 1 missing data [50] - 2 missing data |
|||||||||||||
Statistical analysis title |
Analysis HbA1c - Day 3 | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
39
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.69 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
HbA1c serum level - 3 Months | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
3 Months
|
||||||||||||
|
|||||||||||||
Notes [51] - 2 subjects were retrospectively excluded from analysis due to protocol deviations; 2 missing data |
|||||||||||||
Statistical analysis title |
Analysis HbA1c - 3 Months | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
40
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.595 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Cystatin C serum level - Baseline | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Baseline
|
||||||||||||
|
|||||||||||||
Notes [52] - 2 subjects were retrospectively excluded from analysis due to protocol deviations |
|||||||||||||
Statistical analysis title |
Analysis Cystatin C - Baseline | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
42
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.148 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Cystatin C serum level - Day 1 | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Day 1
|
||||||||||||
|
|||||||||||||
Notes [53] - 2 subjects were retrospectively excluded from analysis due to protocol deviations |
|||||||||||||
Statistical analysis title |
Analysis Cystatin C - Day 1 | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
42
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.001 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Cystatin C serum level - Day 3 | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Day 3
|
||||||||||||
|
|||||||||||||
Notes [54] - 2 subjects were retrospectively excluded from analysis due to protocol deviations; 2 missing data |
|||||||||||||
Statistical analysis title |
Analysis Cystatin C - Day 3 | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
40
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.001 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Cystatin C serum level - 3 Months | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
3 Months
|
||||||||||||
|
|||||||||||||
Notes [55] - 2 subjects were retrospectively excluded from analysis due to protocol deviations; 2 missing data |
|||||||||||||
Statistical analysis title |
Analysis Cystatin C - 3 Months | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
40
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.001 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
NT-proBNP serum level - Baseline | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Baseline
|
||||||||||||
|
|||||||||||||
Notes [56] - 2 subjects were retrospectively excluded from analysis due to protocol deviations |
|||||||||||||
Statistical analysis title |
Analysis NT-proBNP - Baseline | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
42
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.481 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
NT-proBNP serum level - Day 1 | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Day 1
|
||||||||||||
|
|||||||||||||
Notes [57] - 2 subjects were retrospectively excluded from analysis due to protocol deviations |
|||||||||||||
Statistical analysis title |
Analysis NT-proBNP - Day 1 | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
42
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.224 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
NT-proBNP serum level - Day 3 | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Day 3
|
||||||||||||
|
|||||||||||||
Notes [58] - 2 subjects were retrospectively excluded from analysis due to protocol deviations; 1 missing data |
|||||||||||||
Statistical analysis title |
Analysis NT-proBNP - Day 3 | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
41
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.408 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
NT-proBNP serum level - 3 Months | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
3 Months
|
||||||||||||
|
|||||||||||||
Notes [59] - 2 subjects were retrospectively excluded from analysis due to protocol deviations; 3 missing data [60] - 2 missing data |
|||||||||||||
Statistical analysis title |
Analysis NT-proBNP - 3 Months | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
37
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.723 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Aldosterone serum level - Baseline | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Baseline
|
||||||||||||
|
|||||||||||||
Notes [61] - 2 subjects were retrospectively excluded from analysis due to protocol deviations |
|||||||||||||
Statistical analysis title |
Analysis Aldosterone - Baseline | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
42
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.213 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Aldosterone serum level - Day 1 | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Day 1
|
||||||||||||
|
|||||||||||||
Notes [62] - 2 subjects were retrospectively excluded from analysis due to protocol deviations |
|||||||||||||
Statistical analysis title |
Analysis Aldosterone - Day 1 | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
42
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.825 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Aldosterone serum level - Day 3 | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Day 3
|
||||||||||||
|
|||||||||||||
Notes [63] - 2 subjects were retrospectively excluded from analysis due to protocol deviations; 1 missing data |
|||||||||||||
Statistical analysis title |
Analysis Aldosterone - Day 3 | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
41
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.635 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Aldosterone serum level - 3 Months | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
3 Months
|
||||||||||||
|
|||||||||||||
Notes [64] - 2 subjects were retrospectively excluded from analysis due to protocol deviations; 2 missing data |
|||||||||||||
Statistical analysis title |
Analysis Aldosterone - 3 Months | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
40
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.522 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Sodium urine excretion - Baseline | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Baseline
|
||||||||||||
|
|||||||||||||
Notes [65] - 2 subjects were retrospectively excluded from analysis due to protocol deviations [66] - 2 missing data |
|||||||||||||
Statistical analysis title |
Analysis Sodium excretion - Baseline | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
40
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.255 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Sodium urine excretion - Day 1 | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Day 1
|
||||||||||||
|
|||||||||||||
Notes [67] - 2 subjects were retrospectively excluded from analysis due to protocol deviations [68] - 1 missing data |
|||||||||||||
Statistical analysis title |
Analysis Sodium excretion - Day 1 | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
41
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.223 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Sodium urine excretion - Day 3 | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Day 3
|
||||||||||||
|
|||||||||||||
Notes [69] - 2 subjects were retrospectively excluded from analysis due to protocol deviations; 3 missing data [70] - 1 missing data |
|||||||||||||
Statistical analysis title |
Analysis Sodium excretion - Day 3 | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
38
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.97 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Sodium urine excretion - 3 Months | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
3 Months
|
||||||||||||
|
|||||||||||||
Notes [71] - 2 subjects were retrospectively excluded from analysis due to protocol deviations; 4 missing data [72] - 2 missing data |
|||||||||||||
Statistical analysis title |
Analysis Sodium excretion - 3 Months | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
36
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.054 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Glucose urine excretion - Baseline | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Baseline
|
||||||||||||
|
|||||||||||||
Notes [73] - 2 subjects were retrospectively excluded from analysis due to protocol deviations [74] - 2 missing data |
|||||||||||||
Statistical analysis title |
Analysis Glucose excretion - Baseline | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
40
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.617 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Glucose urine excretion - Day 1 | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Day 1
|
||||||||||||
|
|||||||||||||
Notes [75] - 2 subjects were retrospectively excluded from analysis due to protocol deviations [76] - 1 missing data |
|||||||||||||
Statistical analysis title |
Analysis Glucose excretion - Day 1 | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
41
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.001 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Glucose urine excretion - Day 3 | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Day 3
|
||||||||||||
|
|||||||||||||
Notes [77] - 2 subjects were retrospectively excluded from analysis due to protocol deviations; 3 missing data [78] - 1 missing data |
|||||||||||||
Statistical analysis title |
Analysis Glucose excretion - Day 3 | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
38
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.001 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Glucose urine excretion - 3 Months | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
3 Months
|
||||||||||||
|
|||||||||||||
Notes [79] - 2 subjects were retrospectively excluded from analysis due to protocol deviations; 4 missing data [80] - 2 missing data |
|||||||||||||
Statistical analysis title |
Analysis Glucose excretion - 3 Months | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
36
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.001 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Total cholesterol serum level - Baseline | ||||||||||||
End point description |
|||||||||||||
End point type |
Post-hoc
|
||||||||||||
End point timeframe |
Baseline
|
||||||||||||
|
|||||||||||||
Notes [81] - 2 subjects were retrospectively excluded from analysis due to protocol deviations |
|||||||||||||
Statistical analysis title |
Analysis Total Cholesterol - Baseline | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
42
|
||||||||||||
Analysis specification |
Post-hoc
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.257 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Total cholesterol serum level - Day 1 | ||||||||||||
End point description |
|||||||||||||
End point type |
Post-hoc
|
||||||||||||
End point timeframe |
Day 1
|
||||||||||||
|
|||||||||||||
Notes [82] - 2 subjects were retrospectively excluded from analysis due to protocol deviations |
|||||||||||||
Statistical analysis title |
Analysis Total Cholesterol - Day 1 | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
42
|
||||||||||||
Analysis specification |
Post-hoc
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.178 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Total cholesterol serum level - Day 3 | ||||||||||||
End point description |
|||||||||||||
End point type |
Post-hoc
|
||||||||||||
End point timeframe |
Day 3
|
||||||||||||
|
|||||||||||||
Notes [83] - 2 subjects were retrospectively excluded from analysis due to protocol deviations; 1 missing data |
|||||||||||||
Statistical analysis title |
Analysis Total Cholesterol - Day 3 | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
41
|
||||||||||||
Analysis specification |
Post-hoc
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.824 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Total cholesterol serum level - 3 Months | ||||||||||||
End point description |
|||||||||||||
End point type |
Post-hoc
|
||||||||||||
End point timeframe |
3 Months
|
||||||||||||
|
|||||||||||||
Notes [84] - 2 subjects were retrospectively excluded from analysis due to protocol deviations; 2 missing data |
|||||||||||||
Statistical analysis title |
Analysis Total Cholesterol - 3 Months | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
40
|
||||||||||||
Analysis specification |
Post-hoc
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.001 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
LDL-C serum level - Baseline | ||||||||||||
End point description |
|||||||||||||
End point type |
Post-hoc
|
||||||||||||
End point timeframe |
Baseline
|
||||||||||||
|
|||||||||||||
Notes [85] - 2 subjects were retrospectively excluded from analysis due to protocol deviations |
|||||||||||||
Statistical analysis title |
Analysis LDL-C - Baseline | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
42
|
||||||||||||
Analysis specification |
Post-hoc
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.522 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
LDL-C serum level - Day 1 | ||||||||||||
End point description |
|||||||||||||
End point type |
Post-hoc
|
||||||||||||
End point timeframe |
Day 1
|
||||||||||||
|
|||||||||||||
Notes [86] - 2 subjects were retrospectively excluded from analysis due to protocol deviations |
|||||||||||||
Statistical analysis title |
Analysis LDL-C - Day 1 | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
42
|
||||||||||||
Analysis specification |
Post-hoc
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.915 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
LDL-C serum level - Day 3 | ||||||||||||
End point description |
|||||||||||||
End point type |
Post-hoc
|
||||||||||||
End point timeframe |
Day 3
|
||||||||||||
|
|||||||||||||
Notes [87] - 2 subjects were retrospectively excluded from analysis due to protocol deviations; 2 missing data |
|||||||||||||
Statistical analysis title |
Analysis LDL-C - Day 3 | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
40
|
||||||||||||
Analysis specification |
Post-hoc
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.477 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
LDL-C serum level - 3 Months | ||||||||||||
End point description |
|||||||||||||
End point type |
Post-hoc
|
||||||||||||
End point timeframe |
3 Months
|
||||||||||||
|
|||||||||||||
Notes [88] - 2 subjects were retrospectively excluded from analysis due to protocol deviations; 2 missing data |
|||||||||||||
Statistical analysis title |
Analysis LDL-C - 3 Months | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
40
|
||||||||||||
Analysis specification |
Post-hoc
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.001 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
HDL-C serum level - Baseline | ||||||||||||
End point description |
|||||||||||||
End point type |
Post-hoc
|
||||||||||||
End point timeframe |
Baseline
|
||||||||||||
|
|||||||||||||
Notes [89] - 2 subjects were retrospectively excluded from analysis due to protocol deviations |
|||||||||||||
Statistical analysis title |
Analysis HDL-C - Baseline | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
42
|
||||||||||||
Analysis specification |
Post-hoc
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.53 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
HDL-C serum level - Day 1 | ||||||||||||
End point description |
|||||||||||||
End point type |
Post-hoc
|
||||||||||||
End point timeframe |
Day 1
|
||||||||||||
|
|||||||||||||
Notes [90] - 2 subjects were retrospectively excluded from analysis due to protocol deviations |
|||||||||||||
Statistical analysis title |
Analysis HDL-C - Day 1 | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
42
|
||||||||||||
Analysis specification |
Post-hoc
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.947 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
HDL-C serum level - Day 3 | ||||||||||||
End point description |
|||||||||||||
End point type |
Post-hoc
|
||||||||||||
End point timeframe |
Day 3
|
||||||||||||
|
|||||||||||||
Notes [91] - 2 subjects were retrospectively excluded from analysis due to protocol deviations; 1 missing data |
|||||||||||||
Statistical analysis title |
Analysis HDL-C - Day 3 | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
41
|
||||||||||||
Analysis specification |
Post-hoc
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.9 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
HDL-C serum level - 3 Months | ||||||||||||
End point description |
|||||||||||||
End point type |
Post-hoc
|
||||||||||||
End point timeframe |
3 Months
|
||||||||||||
|
|||||||||||||
Notes [92] - 2 subjects were retrospectively excluded from analysis due to protocol deviations; 2 missing data |
|||||||||||||
Statistical analysis title |
Analysis HDL-C - 3 Months | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
40
|
||||||||||||
Analysis specification |
Post-hoc
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.937 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
eGFR - Baseline | ||||||||||||
End point description |
|||||||||||||
End point type |
Post-hoc
|
||||||||||||
End point timeframe |
Baseline
|
||||||||||||
|
|||||||||||||
Notes [93] - 2 subjects were retrospectively excluded from analysis due to protocol deviations |
|||||||||||||
Statistical analysis title |
Analysis eGFR - Baseline | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
42
|
||||||||||||
Analysis specification |
Post-hoc
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.076 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
eGFR - Day 1 | ||||||||||||
End point description |
|||||||||||||
End point type |
Post-hoc
|
||||||||||||
End point timeframe |
Day 1
|
||||||||||||
|
|||||||||||||
Notes [94] - 2 subjects were retrospectively excluded from analysis due to protocol deviations |
|||||||||||||
Statistical analysis title |
Analysis eGFR - Day 1 | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
42
|
||||||||||||
Analysis specification |
Post-hoc
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.014 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
eGFR - Day 3 | ||||||||||||
End point description |
|||||||||||||
End point type |
Post-hoc
|
||||||||||||
End point timeframe |
Day 3
|
||||||||||||
|
|||||||||||||
Notes [95] - 2 subjects were retrospectively excluded from analysis due to protocol deviations; 1 missing data |
|||||||||||||
Statistical analysis title |
Analysis eGFR - Day 3 | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
41
|
||||||||||||
Analysis specification |
Post-hoc
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.039 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
eGFR - 3 Months | ||||||||||||
End point description |
|||||||||||||
End point type |
Post-hoc
|
||||||||||||
End point timeframe |
3 Months
|
||||||||||||
|
|||||||||||||
Notes [96] - 2 subjects were retrospectively excluded from analysis due to protocol deviations; 2 missing data |
|||||||||||||
Statistical analysis title |
Analysis eGFR - 3 Months | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
40
|
||||||||||||
Analysis specification |
Post-hoc
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.108 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Hemoglobin - Baseline | ||||||||||||
End point description |
|||||||||||||
End point type |
Post-hoc
|
||||||||||||
End point timeframe |
Baseline
|
||||||||||||
|
|||||||||||||
Notes [97] - 2 subjects were retrospectively excluded from analysis due to protocol deviations |
|||||||||||||
Statistical analysis title |
Analysis Hemoglobin - Baseline | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
42
|
||||||||||||
Analysis specification |
Post-hoc
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.299 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Hemoglobin - Day 1 | ||||||||||||
End point description |
|||||||||||||
End point type |
Post-hoc
|
||||||||||||
End point timeframe |
Day 1
|
||||||||||||
|
|||||||||||||
Notes [98] - 2 subjects were retrospectively excluded from analysis due to protocol deviations |
|||||||||||||
Statistical analysis title |
Analysis Hemoglobin - Day 1 | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
42
|
||||||||||||
Analysis specification |
Post-hoc
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.487 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Hemoglobin - Day 3 | ||||||||||||
End point description |
|||||||||||||
End point type |
Post-hoc
|
||||||||||||
End point timeframe |
Day 3
|
||||||||||||
|
|||||||||||||
Notes [99] - 2 subjects were retrospectively excluded from analysis due to protocol deviations; 1 missing data |
|||||||||||||
Statistical analysis title |
Analysis Hemoglobin - Day 3 | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
41
|
||||||||||||
Analysis specification |
Post-hoc
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.685 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Hemoglobin - 3 Months | ||||||||||||
End point description |
|||||||||||||
End point type |
Post-hoc
|
||||||||||||
End point timeframe |
3 Months
|
||||||||||||
|
|||||||||||||
Notes [100] - 2 subjects were retrospectively excluded from analysis due to protocol deviations; 2 missing data |
|||||||||||||
Statistical analysis title |
Analysis Hemoglobin - 3 Months | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
40
|
||||||||||||
Analysis specification |
Post-hoc
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.005 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Hematocrit - Baseline | ||||||||||||
End point description |
|||||||||||||
End point type |
Post-hoc
|
||||||||||||
End point timeframe |
Baseline
|
||||||||||||
|
|||||||||||||
Notes [101] - 2 subjects were retrospectively excluded from analysis due to protocol deviations |
|||||||||||||
Statistical analysis title |
Analysis Hematocrit - Baseline | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
42
|
||||||||||||
Analysis specification |
Post-hoc
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.284 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Hematocrit - Day 1 | ||||||||||||
End point description |
|||||||||||||
End point type |
Post-hoc
|
||||||||||||
End point timeframe |
Day 1
|
||||||||||||
|
|||||||||||||
Notes [102] - 2 subjects were retrospectively excluded from analysis due to protocol deviations |
|||||||||||||
Statistical analysis title |
Analysis Hematocrit - Day 1 | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
42
|
||||||||||||
Analysis specification |
Post-hoc
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.761 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Hematocrit - Day 3 | ||||||||||||
End point description |
|||||||||||||
End point type |
Post-hoc
|
||||||||||||
End point timeframe |
Day 3
|
||||||||||||
|
|||||||||||||
Notes [103] - 2 subjects were retrospectively excluded from analysis due to protocol deviations; 1 missing data |
|||||||||||||
Statistical analysis title |
Analysis Hematocrit - Day 3 | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
41
|
||||||||||||
Analysis specification |
Post-hoc
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.93 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Hematocrit - 3 Months | ||||||||||||
End point description |
|||||||||||||
End point type |
Post-hoc
|
||||||||||||
End point timeframe |
3 Months
|
||||||||||||
|
|||||||||||||
Notes [104] - 2 subjects were retrospectively excluded from analysis due to protocol deviations; 2 missing data |
|||||||||||||
Statistical analysis title |
Analysis Hematocrit - 3 Months | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
40
|
||||||||||||
Analysis specification |
Post-hoc
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.001 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Urinary volume - Baseline | ||||||||||||
End point description |
|||||||||||||
End point type |
Post-hoc
|
||||||||||||
End point timeframe |
Baseline
|
||||||||||||
|
|||||||||||||
Notes [105] - 2 subjects were retrospectively excluded from analysis due to protocol deviations [106] - 2 missing data |
|||||||||||||
Statistical analysis title |
Analysis Urinary volume - Baseline | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
40
|
||||||||||||
Analysis specification |
Post-hoc
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.829 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Urinary volume - Day 1 | ||||||||||||
End point description |
|||||||||||||
End point type |
Post-hoc
|
||||||||||||
End point timeframe |
Day 1
|
||||||||||||
|
|||||||||||||
Notes [107] - 2 subjects were retrospectively excluded from analysis due to protocol deviations [108] - 1 missing data |
|||||||||||||
Statistical analysis title |
Analysis Urinary volume - Day 1 | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
41
|
||||||||||||
Analysis specification |
Post-hoc
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.011 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Urinary volume - Day 3 | ||||||||||||
End point description |
|||||||||||||
End point type |
Post-hoc
|
||||||||||||
End point timeframe |
Day 3
|
||||||||||||
|
|||||||||||||
Notes [109] - 2 subjects were retrospectively excluded from analysis due to protocol deviations; 2 missing data [110] - 1 missing data |
|||||||||||||
Statistical analysis title |
Analysis Urinary volume - Day 3 | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
39
|
||||||||||||
Analysis specification |
Post-hoc
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.429 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Urinary volume - 3 Months | ||||||||||||
End point description |
|||||||||||||
End point type |
Post-hoc
|
||||||||||||
End point timeframe |
3 Months
|
||||||||||||
|
|||||||||||||
Notes [111] - 2 subjects were retrospectively excluded from analysis due to protocol deviations; 4 missing data [112] - 1 missing data |
|||||||||||||
Statistical analysis title |
Analysis Urinary volume - 3 Months | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
37
|
||||||||||||
Analysis specification |
Post-hoc
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.001 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Electrolyte-free water clearance - Baseline | ||||||||||||
End point description |
|||||||||||||
End point type |
Post-hoc
|
||||||||||||
End point timeframe |
Baseline
|
||||||||||||
|
|||||||||||||
Notes [113] - 2 subjects were retrospectively excluded from analysis due to protocol deviations [114] - 2 missing data |
|||||||||||||
Statistical analysis title |
Analysis EF WC - Baseline | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
40
|
||||||||||||
Analysis specification |
Post-hoc
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.467 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Electrolyte-free water clearance - Day 1 | ||||||||||||
End point description |
|||||||||||||
End point type |
Post-hoc
|
||||||||||||
End point timeframe |
Day 1
|
||||||||||||
|
|||||||||||||
Notes [115] - 2 subjects were retrospectively excluded from analysis due to protocol deviations [116] - 1 missing data |
|||||||||||||
Statistical analysis title |
Analysis EF WC - Day 1 | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
41
|
||||||||||||
Analysis specification |
Post-hoc
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.011 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Electrolyte-free water clearance - Day 3 | ||||||||||||
End point description |
|||||||||||||
End point type |
Post-hoc
|
||||||||||||
End point timeframe |
Day 3
|
||||||||||||
|
|||||||||||||
Notes [117] - 2 subjects were retrospectively excluded from analysis due to protocol deviations; 3 missing data [118] - 1 missing data |
|||||||||||||
Statistical analysis title |
Analysis EF WC - Day 3 | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
38
|
||||||||||||
Analysis specification |
Post-hoc
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.07 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Electrolyte-free water clearance - 3 Months | ||||||||||||
End point description |
|||||||||||||
End point type |
Post-hoc
|
||||||||||||
End point timeframe |
3 Months
|
||||||||||||
|
|||||||||||||
Notes [119] - 2 subjects were retrospectively excluded from analysis due to protocol deviations; 4 missing data [120] - 2 missing data |
|||||||||||||
Statistical analysis title |
Analysis EF WC - 3 Months | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
36
|
||||||||||||
Analysis specification |
Post-hoc
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.013 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Left ventricular enddiastolic diameter - Baseline | ||||||||||||
End point description |
|||||||||||||
End point type |
Post-hoc
|
||||||||||||
End point timeframe |
Baseline
|
||||||||||||
|
|||||||||||||
Notes [121] - 2 subjects were retrospectively excluded from analysis due to protocol deviations; 2 missing data |
|||||||||||||
Statistical analysis title |
Analysis LVEDD - Baseline | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
40
|
||||||||||||
Analysis specification |
Post-hoc
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.365 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Left ventricular enddiastolic diameter - Day 1 | ||||||||||||
End point description |
|||||||||||||
End point type |
Post-hoc
|
||||||||||||
End point timeframe |
Day 1
|
||||||||||||
|
|||||||||||||
Notes [122] - 2 subjects were retrospectively excluded from analysis due to protocol deviations; 2 missing data |
|||||||||||||
Statistical analysis title |
Analysis LVEDD - Day 1 | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
40
|
||||||||||||
Analysis specification |
Post-hoc
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.864 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Left ventricular enddiastolic diameter - Day 3 | ||||||||||||
End point description |
|||||||||||||
End point type |
Post-hoc
|
||||||||||||
End point timeframe |
Day 3
|
||||||||||||
|
|||||||||||||
Notes [123] - 2 subjects were retrospectively excluded from analysis due to protocol deviations; 2 missing data |
|||||||||||||
Statistical analysis title |
Analysis LVEDD - Day 3 | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
40
|
||||||||||||
Analysis specification |
Post-hoc
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.449 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Left ventricular enddiastolic diameter - 3 Months | ||||||||||||
End point description |
|||||||||||||
End point type |
Post-hoc
|
||||||||||||
End point timeframe |
3 Months
|
||||||||||||
|
|||||||||||||
Notes [124] - 2 subjects were retrospectively excluded from analysis due to protocol deviations; 2 missing data |
|||||||||||||
Statistical analysis title |
Analysis LVEDD - 3 Months | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
40
|
||||||||||||
Analysis specification |
Post-hoc
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.994 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Left ventricular endsystolic diameter - Baseline | ||||||||||||
End point description |
|||||||||||||
End point type |
Post-hoc
|
||||||||||||
End point timeframe |
Baseline
|
||||||||||||
|
|||||||||||||
Notes [125] - 2 subjects were retrospectively excluded from analysis due to protocol deviations; 2 missing data |
|||||||||||||
Statistical analysis title |
Analysis LVESD - Baseline | ||||||||||||
Comparison groups |
Placebo v Empagliflozin
|
||||||||||||
Number of subjects included in analysis |
40
|
||||||||||||
Analysis specification |
Post-hoc
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.386 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Left ventricular endsystolic diameter - Day 1 | ||||||||||||
End point description |
|||||||||||||
End point type |
Post-hoc
|
||||||||||||
End point timeframe |
Day 1
|
||||||||||||
|
|||||||||||||
Notes [126] - 2 subjects were retrospectively excluded from analysis due to protocol deviations; 2 missing data |
|||||||||||||
Statistical analysis title |
Analysis LVESD - Day 1 | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
40
|
||||||||||||
Analysis specification |
Post-hoc
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.595 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Left ventricular endsystolic diameter - Day 3 | ||||||||||||
End point description |
|||||||||||||
End point type |
Post-hoc
|
||||||||||||
End point timeframe |
Day 3
|
||||||||||||
|
|||||||||||||
Notes [127] - 2 subjects were retrospectively excluded from analysis due to protocol deviations; 2 missing data |
|||||||||||||
Statistical analysis title |
Analysis LVESD - Day 3 | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
40
|
||||||||||||
Analysis specification |
Post-hoc
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.187 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Left ventricular endsystolic diameter - 3 Months | ||||||||||||
End point description |
|||||||||||||
End point type |
Post-hoc
|
||||||||||||
End point timeframe |
3 Months
|
||||||||||||
|
|||||||||||||
Notes [128] - 2 subjects were retrospectively excluded from analysis due to protocol deviations; 2 missing data |
|||||||||||||
Statistical analysis title |
Analysis LVESD - 3 Months | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
40
|
||||||||||||
Analysis specification |
Post-hoc
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.284 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Interventricular septum in diastole - Baseline | ||||||||||||
End point description |
|||||||||||||
End point type |
Post-hoc
|
||||||||||||
End point timeframe |
Baseline
|
||||||||||||
|
|||||||||||||
Notes [129] - 2 subjects were retrospectively excluded from analysis due to protocol deviations; 2 missing data |
|||||||||||||
Statistical analysis title |
Analysis IVSd - Baseline | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
40
|
||||||||||||
Analysis specification |
Post-hoc
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.94 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Interventricular septum in diastole - Day 1 | ||||||||||||
End point description |
|||||||||||||
End point type |
Post-hoc
|
||||||||||||
End point timeframe |
Day 1
|
||||||||||||
|
|||||||||||||
Notes [130] - 2 subjects were retrospectively excluded from analysis due to protocol deviations; 2 missing data |
|||||||||||||
Statistical analysis title |
Analysis IVSd - Day 1 | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
40
|
||||||||||||
Analysis specification |
Post-hoc
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.764 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Interventricular septum in diastole - Day 3 | ||||||||||||
End point description |
|||||||||||||
End point type |
Post-hoc
|
||||||||||||
End point timeframe |
Day 3
|
||||||||||||
|
|||||||||||||
Notes [131] - 2 subjects were retrospectively excluded from analysis due to protocol deviations; 2 missing data |
|||||||||||||
Statistical analysis title |
Analysis IVSd - Day 3 | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
40
|
||||||||||||
Analysis specification |
Post-hoc
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.63 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Interventricular septum in diastole - 3 Months | ||||||||||||
End point description |
|||||||||||||
End point type |
Post-hoc
|
||||||||||||
End point timeframe |
3 Months
|
||||||||||||
|
|||||||||||||
Notes [132] - 2 subjects were retrospectively excluded from analysis due to protocol deviations; 2 missing data |
|||||||||||||
Statistical analysis title |
Analysis IVSd - 3 Months | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
40
|
||||||||||||
Analysis specification |
Post-hoc
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.497 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|
|||||||||||||
End point title |
Left ventricular mass index - Baseline | ||||||||||||
End point description |
|||||||||||||
End point type |
Post-hoc
|
||||||||||||
End point timeframe |
Baseline
|
||||||||||||
|
|||||||||||||
Notes [133] - 2 subjects were retrospectively excluded from analysis due to protocol deviations; 2 missing data |
|||||||||||||
Statistical analysis title |
Analysis LV MI - Baseline | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
|
||||||||||||
Number of subjects included in analysis |
40
|
||||||||||||
Analysis specification |
Post-hoc
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.474 | ||||||||||||
Method |
Wald test | ||||||||||||
Confidence interval |
|