Clinical Trial Results:
A 24-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled,
International Phase III Study with a 28-week Extension Period to Evaluate
the Safety and Efficacy of Dapagliflozin 10mg once daily in Patients with
Type 2 Diabetes who have Inadequate Glycaemic Control on a background
combination of Metformin and Sulfonylurea
Summary
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EudraCT number |
2011-002231-26 |
Trial protocol |
DE CZ SK ES |
Global end of trial date |
12 Aug 2013
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Results information
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Results version number |
v1(current) |
This version publication date |
12 May 2016
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First version publication date |
12 May 2016
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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 |
D1693C00005
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01392677 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
AstraZeneca
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Sponsor organisation address |
Pepparedsleden1, Molndal, Sweden, SF-431 83
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Public contact |
Eva Johnsson, Astra Zeneca, ClinicalTrialTransparency@astrazeneca.com
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Scientific contact |
Eva Johnsson, Astra Zeneca, ClinicalTrialTransparency@astrazeneca.com
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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 |
18 Jul 2013
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
12 Aug 2013
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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 |
The main objective of this study was to compare the change from baseline in HbA1c to
week 24 between dapagliflozin 10 mg in combination with metformin and SU and placebo in
combination with metformin and SU.
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Protection of trial subjects |
This study was performed in accordance with the ethical principles that have their origin in the
Declaration of Helsinki and that are consistent with International Conference on Harmonisation/Good
Clinical Practice (GCP) and applicable regulatory requirements and the AstraZeneca policy on Bioethics and Human Biological Samples. The investigator at each center ensured that the patient, parent, guardian, or legal representative (as appropriate) was given full and adequate oral and written information about the nature, purpose, possible risk, and benefit of the study. The patient, parent, guardian, or legal representative (as appropriate) were notified that they were free to discontinue from the study at any time and were given the opportunity to ask questions and allowed time to consider the information provided.
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Background therapy |
Stable dose combination therapy of metformin at least 1500 mg each day and maximum tolerated dose which must be at least half maximum dose of sulfonylurea for at least 8 weeks prior to enrolment. | ||
Evidence for comparator |
Placebo-controlled. | ||
Actual start date of recruitment |
24 Oct 2011
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Long term follow-up planned |
Yes
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Long term follow-up rationale |
Safety, Efficacy | ||
Long term follow-up duration |
6 Months | ||
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 |
Canada: 55
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Country: Number of subjects enrolled |
Germany: 26
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Country: Number of subjects enrolled |
Poland: 47
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Country: Number of subjects enrolled |
Slovakia: 36
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Country: Number of subjects enrolled |
Spain: 26
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Country: Number of subjects enrolled |
Czech Republic: 28
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Worldwide total number of subjects |
218
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EEA total number of subjects |
163
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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) |
142
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From 65 to 84 years |
76
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85 years and over |
0
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Recruitment
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Recruitment details |
Of 859 participants enrolled, 736 completed the qualification phase. Of these 597 subjects were randomized and 596 received treatment and 262 were excluded due to adverse events (4), incorrect enrollment (229), withdrawn consent (23), lost to follow-up (2), and other reasons (4). | |||||||||||||||||||||
Pre-assignment
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Screening details |
During enrollment, diet and life-style advice was given to participants and was reinforced during a placebo lead-in period. Dose of anti-hyperglycemic combination therapy of metformin >= 1500 mg/day and maximum tolerated dose which must be at least half the maximum dose of sulfonylurea for at least 8 weeks prior to enrollment were to remain stable. | |||||||||||||||||||||
Period 1
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Period 1 title |
24-week Double-Blind (Full Analysis Set) (overall period)
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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, Carer, Data analyst, Assessor | |||||||||||||||||||||
Blinding implementation details |
Double-blind
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Placebo plus metformin plus sulfonylurea | |||||||||||||||||||||
Arm description |
Placebo | |||||||||||||||||||||
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 |
QD
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Arm title
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Dapagliflozin 10 mg plus metformin plus sulfonylurea | |||||||||||||||||||||
Arm description |
Dapagliflozn 10 mg | |||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||
Investigational medicinal product name |
Dapagliflozin
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Investigational medicinal product code |
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Other name |
Farxiga
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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 oral administration
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Notes [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: Baseline summaries represent the full analysis set (FAS) and was provided to correspond with the analysis set evaluated in efficacy analyses. This population required subjects to receive at least one dose of study medication, and to have baseline and post-treatment assessments available for at least one efficacy parameter.The number of subjects in the FAS is less than the the number worldwide subjects enrolled in the trial |
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Baseline characteristics reporting groups
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Reporting group title |
Placebo plus metformin plus sulfonylurea
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Reporting group description |
Placebo | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Dapagliflozin 10 mg plus metformin plus sulfonylurea
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Reporting group description |
Dapagliflozn 10 mg | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
Full Analysis Set
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Subject analysis set type |
Full analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Randomized subjects that received at least 1 dose of double-blind study medication, with a baseline and at least 1 post-baseline assessment for an efficacy paramter.
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End points reporting groups
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Reporting group title |
Placebo plus metformin plus sulfonylurea
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Reporting group description |
Placebo | ||
Reporting group title |
Dapagliflozin 10 mg plus metformin plus sulfonylurea
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Reporting group description |
Dapagliflozn 10 mg | ||
Subject analysis set title |
Full Analysis Set
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Randomized subjects that received at least 1 dose of double-blind study medication, with a baseline and at least 1 post-baseline assessment for an efficacy paramter.
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End point title |
Adjusted mean change from baseline in Hemoglobin A1C (HbA1c) at Week 24 (Repeated Measures Model [RMM]) | ||||||||||||
End point description |
HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the startdate and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment onor prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 8, 12, 16, and 24 in the double-blind period.
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End point type |
Primary
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End point timeframe |
From Baseline to Week 24
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Statistical analysis title |
Primary Endpoint Analysis | ||||||||||||
Statistical analysis description |
H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0
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Comparison groups |
Placebo plus metformin plus sulfonylurea v Dapagliflozin 10 mg plus metformin plus sulfonylurea
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Number of subjects included in analysis |
216
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
< 0.0001 [1] | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
-0.69
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-0.89 | ||||||||||||
upper limit |
-0.49 | ||||||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
0.1022
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Notes [1] - Significant at alpha=0.05 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary & key secondary objectives |
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End point title |
Adjusted mean change from baseline in FPG at Week 24 (Last Observation Carried Forward [LOCF]) | ||||||||||||
End point description |
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Data after rescue medication was excluded from this analysis. Fasting plasma glucose was measured as milligrams per deciliter (mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.
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End point type |
Secondary
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End point timeframe |
Baseline to week 24
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Statistical analysis title |
First Secondary Endpoint Analysis | ||||||||||||
Statistical analysis description |
H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0
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Comparison groups |
Placebo plus metformin plus sulfonylurea v Dapagliflozin 10 mg plus metformin plus sulfonylurea
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Number of subjects included in analysis |
215
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Analysis specification |
Pre-specified
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Analysis type |
superiority [2] | ||||||||||||
P-value |
< 0.0001 [3] | ||||||||||||
Method |
ANCOVA | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
-33.45
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-43.08 | ||||||||||||
upper limit |
-23.82 | ||||||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
4.8846
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Notes [2] - Last Observation Carried Forward (LOCF) [3] - Significant at alpha=0.05 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary & key secondary objectives |
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End point title |
Adjusted Mean Change From Baseline in Total Body Weight at Week 24 (Last Observation Carried Forward [LOCF]) | ||||||||||||
End point description |
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1and Weeks 4, 8, 16, and 24 of the double-blind period.
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End point type |
Secondary
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End point timeframe |
Baseline to week 24
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Statistical analysis title |
Second Secondary Endpoint Analysis | ||||||||||||
Statistical analysis description |
HA: mean(treat) minus mean(placebo) =/= 0
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Comparison groups |
Placebo plus metformin plus sulfonylurea v Dapagliflozin 10 mg plus metformin plus sulfonylurea
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Number of subjects included in analysis |
216
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Analysis specification |
Pre-specified
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Analysis type |
superiority [4] | ||||||||||||
P-value |
< 0.0001 [5] | ||||||||||||
Method |
ANCOVA | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
-2.07
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-2.79 | ||||||||||||
upper limit |
-1.35 | ||||||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
0.3651
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Notes [4] - Last Observation Carried Forward (LOCF) [5] - Significant at alpha=0.05 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary & key secondary objectives |
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End point title |
Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF]) | ||||||||||||
End point description |
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Percent adjusted for baseline HbA1c. Therapeutic glycemic response is defined as HbA1c <7.0%. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.
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End point type |
Secondary
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End point timeframe |
Baseline to week 24
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Statistical analysis title |
Third Secondary Endpoint Analysis | ||||||||||||
Statistical analysis description |
H0: proportion(treat) minus proportion (placebo) = 0 versus the alternative HA: proportion (treat) minus proportion (placebo) =/= 0
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Comparison groups |
Placebo plus metformin plus sulfonylurea v Dapagliflozin 10 mg plus metformin plus sulfonylurea
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Number of subjects included in analysis |
216
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Analysis specification |
Pre-specified
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Analysis type |
superiority [6] | ||||||||||||
P-value |
< 0.0001 [7] | ||||||||||||
Method |
Regression, Logistic | ||||||||||||
Parameter type |
Risk difference (RD) | ||||||||||||
Point estimate |
20.7
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
10.7 | ||||||||||||
upper limit |
30.6 | ||||||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
5.056
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Notes [6] - Last Observation Carried Forward (LOCF) [7] - Significant at alpha=0.05 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary & key secondary objectives |
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End point title |
Adjusted Mean Change from Baseline in Seated Systolic Blood Pressure at Week 8 (Last Observation Carried Forward [LOCF]) | ||||||||||||
End point description |
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined.) Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was definedas the last assessment on or prior to the date of the first dose of the double-blind study medication. Systolic blood pressure measurements were obtained during the qualification and lead-in Periods and on Day 1 and Weeks 4, 8, 16, and 24 of the double-blind period.
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End point type |
Secondary
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End point timeframe |
From Baseline to week 8
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Statistical analysis title |
Fourth Secondary Endpoint Analysis | ||||||||||||
Statistical analysis description |
H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0
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Comparison groups |
Placebo plus metformin plus sulfonylurea v Dapagliflozin 10 mg plus metformin plus sulfonylurea
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Number of subjects included in analysis |
210
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Analysis specification |
Pre-specified
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Analysis type |
superiority [8] | ||||||||||||
P-value |
= 0.025 [9] | ||||||||||||
Method |
ANCOVA | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
-3.76
|
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Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-7.05 | ||||||||||||
upper limit |
-0.48 | ||||||||||||
Variability estimate |
Standard error of the mean
|
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Dispersion value |
1.6677
|
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Notes [8] - Last Obaservation Carried Forward (LOCF) [9] - Significant at alpha=0.05 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary & key secondary objectives |
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Adverse events information [1]
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Timeframe for reporting adverse events |
Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 52-week double-blind treatment plus 4/30 days or up to follow-up visit if earlier, or up to and including the start date of extension period if earlier.
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Adverse event reporting additional description |
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
15.1
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Reporting groups
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Reporting group title |
Dapagliflozin 10mg plus metformin plus sulfonylurea
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Reporting group description |
Dapagliflozin 10mg once daily plus background combination of metformin and sulfonylurea | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo plus metformin plus sulfonylurea
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Reporting group description |
Placebo once daily plus background combination of metformin and sulfonylurea | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: The number of non-serious AEs was not reported in the clinical study report in accordance with safety analysis conventions which required the numbers and percentages of subjects that experienced at least one non-serious adverse event. As the number of non-serious AEs and the corresponding numbers and percentages of subjects that experienced at least one non-serious event were not both available in the clinical study report, the absence of complete data as required could not be reported |
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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. | |||
Last observation carried forward (LOCF) was used for analyses of secondary endpoints. All endpoints excluded data after rescue.Disposition for the full analysis set had fewer subjects than adverse event summaries, and fewer subjects than enrolled. | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/25592197 |