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Efficacy and Safety in Patients With Type 2 Diabetes Mellitus and Cardiovascular Disease

This study has been completed.
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: January 5, 2010
Last updated: December 18, 2013
Last verified: December 2013
Results First Received: January 21, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Type 2 Diabetes Mellitus
Cardiovascular Disease
Inadequate Glycaemic Control
Interventions: Drug: Dapagliflozin
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First participant enrolled 15 Mar 2010, last part. last visit for 24-week period: 30 May 2011. 1489 part. enrolled, 964 randomized in USA, Canada, Australia, Chile, Argentina and 5 European countries (value presented in ‘Enrolment’ field). One add. part. treated but not randomized. Part. with T2DM and CVD who showed inadequate glycemic control.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
During a placebo lead-in period, participants were counselled on dietary and life-style modifications. Anti-diabetic therapy should be kept constant 4 weeks prior to enrolment. Participants eligible for the study were stratified according to age (<65 years or ≥65 years), insulin use and time from most recent qualifying CV event (>1 or ≤1 year).

Reporting Groups
Dapagliflozin Dapagliflozin 10 mg plus usual care
Placebo Placebo plus usual care

Participant Flow:   Overall Study
    Dapagliflozin   Placebo
STARTED   482 [1]   483 [2] 
COMPLETED   441   428 
NOT COMPLETED   41   55 
Adverse Event                4                12 
Death                2                1 
Withdrawal by Subject                8                16 
Lost to Follow-up                0                2 
Poor/non-compliance                3                4 
Subject no longer meets study criteria                15                13 
Incorrect enrollment                6                4 
Safety                0                2 
Administrative reason by sponsor                0                1 
Various                3                0 
[1] Of 482 part. 480 were included in full analysis set. Thereof, 1 part. treated but not randomized.
[2] Of the 483 participants only 482 were included in the full analysis set.

  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set defined as all randomized participants (as randomized) who received at least one dose of double-blind study medication, who have a non-missing baseline value and at least one post-baseline efficacy value for at least one efficacy variable during double-blind treatment period.

Reporting Groups
Dapagliflozin Dapagliflozin 10 mg plus usual care
Placebo Placebo plus usual care
Total Total of all reporting groups

Baseline Measures
   Dapagliflozin   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 480   482   962 
[Units: Years]
Mean (Standard Deviation)
 63.9  (7.60)   63.6  (7.02)   63.8  (7.31) 
[Units: Participants]
Female   159   159   318 
Male   321   323   644 
Race/Ethnicity, Customized 
[Units: Participants]
White   454   449   903 
Black/African American   9   10   19 
Asian   6   7   13 
Other   11   16   27 
[Units: Percent]
Mean (Standard Deviation)
 8.04  (0.759)   8.08  (0.795)   8.06  (0.777) 
Body weight 
[Units: Kg]
Mean (Standard Deviation)
 94.53  (17.804)   93.23  (16.842)   93.88  (17.332) 
Systolic Blood Pressure 
[Units: mmHg]
Mean (Standard Deviation)
 134.9  (14.53)   134.6  (13.96)   134.7  (14.24) 
Number of participants with BMI >= 27 kg/m2 at baseline 
[Units: Participants]
< 25 kg/m²   15   31   46 
>= 25 kg/m²   465   451   916 
>= 27 kg/m²   428   416   844 
>= 30 kg/m²   339   325   664 

  Outcome Measures
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1.  Primary:   Adjusted Mean Change in HbA1c Levels   [ Time Frame: Baseline to Week 24 ]

2.  Primary:   Proportion of Responders Meeting All Criteria of a 3-item Endpoint of Clinical Benefit   [ Time Frame: Baseline to Week 24 ]

3.  Secondary:   Adjusted Mean Percent Change in Body Weight   [ Time Frame: Baseline to Week 24 ]

4.  Secondary:   Proportion of Participants With a Reduction From Baseline of 5% or More in Body Weight in Participants With Baseline BMI ≥27 kg/m²   [ Time Frame: Baseline to Week 24 ]

5.  Secondary:   Adjusted Mean Change in Systolic Blood Pressure at Week 8 (LOCF)   [ Time Frame: Baseline to Week 8 ]

6.  Secondary:   Adjusted Mean Change in Seated Systolic Blood Pressure at Week 24 (LOCF)   [ Time Frame: Baseline to Week 24 ]

7.  Secondary:   Adjusted Mean Change in Seated Systolic Blood Pressure (SBP) at Week 8 (LOCF) in Participants With Baseline SBP>=130 mmHg   [ Time Frame: Baseline to Week 8 ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
For participants who did not complete 8 and/or 24 weeks, respectively, LOCF was used. For HbA1c: excluding data after glycemic rescue, Weight: including data after rescue, SBP: excluding data after anti-hypertensive rescue.

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