Clinical Trial Results:
The effects of SGLT2-inhibition in patients with type 2 diabetes and chronic kidney disease on renal hemodynamics, kidney function and vasoactive hormones
Summary
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EudraCT number |
2019-004447-80 |
Trial protocol |
DK |
Global end of trial date |
03 Jan 2023
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Results information
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Results version number |
v1(current) |
This version publication date |
22 Feb 2025
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First version publication date |
22 Feb 2025
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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 |
SFN-2-2019
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
University Clinic of Nephrology and Hypertension, Regional Hospital Holstebro
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Sponsor organisation address |
Hospitalparken 15 , Herning, Denmark, 7400
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Public contact |
Steffen Flindt Nielsen, University Clinic of Nephrology and Hypertension, Regional Hospital Holstebro, 0045 78436588, steffen.nielsen@midt.rm.dk
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Scientific contact |
Steffen Flindt Nielsen, University Clinic of Nephrology and Hypertension, Regional Hospital Holstebro, 0045 78436588, steffen.nielsen@midt.rm.dk
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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 |
03 Jan 2023
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
03 Jan 2023
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Global end of trial reached? |
Yes
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Global end of trial date |
03 Jan 2023
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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 |
To examine the effects of SGLT2-inhibition versus placebo on renal hemodynamics in patients with type 2 diabetes and chronic kidney disease
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Protection of trial subjects |
NA
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Mar 2021
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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 |
Denmark: 19
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Worldwide total number of subjects |
19
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EEA total number of subjects |
19
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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) |
5
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From 65 to 84 years |
14
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||||
Pre-assignment
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Screening details |
- | ||||||||||||
Pre-assignment period milestones
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Number of subjects started |
19 | ||||||||||||
Number of subjects completed |
19 | ||||||||||||
Period 1
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Period 1 title |
Placebo
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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, Monitor, Data analyst, Carer | ||||||||||||
Arms
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Arm title
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Placebo | ||||||||||||
Arm description |
- | ||||||||||||
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 |
1 tablet x 1 day
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Period 2
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Period 2 title |
Empaglilfozin
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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, Monitor, Data analyst, Carer, Assessor | ||||||||||||
Arms
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Arm title
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Empagliflozin | ||||||||||||
Arm description |
- | ||||||||||||
Arm type |
Active comparator | ||||||||||||
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 x 1 daily
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Baseline characteristics reporting groups
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Reporting group title |
Placebo
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Reporting group description |
- | |||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Placebo
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Reporting group description |
- | ||
Reporting group title |
Empagliflozin
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Reporting group description |
- |
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End point title |
Renal Blood Flow | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
at the end of each period
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Statistical analysis title |
paired t-test | ||||||||||||
Comparison groups |
Placebo v Empagliflozin
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Number of subjects included in analysis |
32
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
< 0.001 | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
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End point title |
GFR | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
at the end of each period
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Statistical analysis title |
paired t-test | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
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Number of subjects included in analysis |
34
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.019 | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
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End point title |
RVR | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
at the end of each period
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Statistical analysis title |
paired t-test | ||||||||||||
Comparison groups |
Placebo v Empagliflozin
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Number of subjects included in analysis |
34
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.6 | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
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End point title |
Systolic blood pressure | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
at the end of each period
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Statistical analysis title |
paired t-test | ||||||||||||
Comparison groups |
Placebo v Empagliflozin
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Number of subjects included in analysis |
34
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.0097 | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
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End point title |
diastolic blood pressure | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
at the end of each period
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Statistical analysis title |
paired t-test | ||||||||||||
Comparison groups |
Placebo v Empagliflozin
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Number of subjects included in analysis |
34
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.043 | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
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End point title |
TVR | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
at the end of each period
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Statistical analysis title |
paired t-test | ||||||||||||
Comparison groups |
Empagliflozin v Placebo
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Number of subjects included in analysis |
34
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.02 | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
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End point title |
heart rate | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
at the end of each period
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Statistical analysis title |
paired t-test | ||||||||||||
Comparison groups |
Placebo v Empagliflozin
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Number of subjects included in analysis |
34
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.15 | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
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Adverse events information
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Timeframe for reporting adverse events |
From the begining of the trial to LPLV + 1 week
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
21
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Reporting groups
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Reporting group title |
total trial
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |