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

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01042977
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;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Type 2 Diabetes Mellitus
Cardiovascular Disease
Inadequate Glycaemic Control
Interventions: Drug: Dapagliflozin
Drug: Placebo

  Participant Flow


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

Baseline Measures
    Dapagliflozin     Placebo     Total  
Number of Participants  
[units: participants]
  480     482     962  
Age  
[units: Years]
Mean ± Standard Deviation
  63.9  ± 7.60     63.6  ± 7.02     63.8  ± 7.31  
Gender  
[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  
HbA1c  
[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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