Efficacy and Safety of Dapagliflozin in Combination With Metformin in Type 2 Diabetes Patients

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00660907
First received: April 15, 2008
Last updated: September 24, 2013
Last verified: September 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
Condition: Type 2 Diabetes
Interventions: Drug: dapagliflozin
Drug: glipizide
Drug: metformin hydrochloride

  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
The first participant enrolled on 31 March 2008. The last participant last visit was on 15 December 2009. 1901 participants were screened and 1217 participants were enrolled to randomize 816 participants. This study was conducted at 95 centers world-wide. Two randomized patients were excluded because they didn’t receive any dose of study medication

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
For participants with a metformin dose of less than 1500 mg/day, a change in metformin dose in the past 8 weeks or on an Oral Anti-Diabetic (OAD), an 8-week metformin-only dose stabilisation period occurred. A 2-week placebo lead in period occurred after the dose stabilisation period or after enrolment if dose stabilisation period was skipped.

Reporting Groups
  Description
Dapagliflozin Plus Metformin Experimental dapagliflozin plus metformin
Glipizide Plus Metformin Active Comparator glipizide plus metformin

Participant Flow:   Overall Study
    Dapagliflozin Plus Metformin     Glipizide Plus Metformin  
STARTED     406 [1]   408 [2]
COMPLETED     322     314  
NOT COMPLETED     84     94  
Incorrect Enrollment                 1                 1  
Adverse Event                 33                 19  
Subject No Longer Meets Study Criteria                 6                 27  
Withdrawal by Subject                 23                 32  
Lost to Follow-up                 3                 3  
Poor/Non-Compliance                 5                 1  
Safety                 1                 0  
Death                 1                 3  
Various                 11                 8  
[1] Of the 406 randomized participants only 400 were included in the full analysis set.
[2] Of the 408 randomized participants only 401 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
  Description
Dapagliflozin Plus Metformin Experimental dapagliflozin plus metformin
Glipizide Plus Metformin Active Comparator glipizide plus metformin
Total Total of all reporting groups

Baseline Measures
    Dapagliflozin Plus Metformin     Glipizide Plus Metformin     Total  
Number of Participants  
[units: participants]
  400     401     801  
Age  
[units: years]
Mean ± Standard Deviation
  58.1  ± 9.37     58.6  ± 9.80     58.4  ± 9.58  
Gender  
[units: Participants]
     
Female     179     181     360  
Male     221     220     441  
Race/Ethnicity, Customized  
[units: Participants]
     
American Indian or Alaska Native     0     0     0  
Asian     27     34     61  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     26     24     50  
White     327     323     650  
More than one race     0     0     0  
Unknown or Not Reported     20     20     40  
BMI  
[units: kg/m2]
Mean ± Standard Deviation
  31.71  ± 5.104     31.23  ± 5.053     31.47  ± 5.081  
HbA1c  
[units: percent]
Mean ± Standard Deviation
  7.69  ± 0.855     7.74  ± 0.886     7.72  ± 0.870  
FPG  
[units: ng/mL]
Mean ± Standard Deviation
  162.24  ± 37.796     163.91  ± 41.559     163.07  ± 39.708  



  Outcome Measures
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1.  Primary:   Adjusted Mean Change in HbA1c Levels   [ Time Frame: Baseline to Week 52 ]

2.  Secondary:   Adjusted Mean Change in Body Weight   [ Time Frame: Baseline to Week 52 ]

3.  Secondary:   Proportion of Participants With at Least One Episode of Hypoglycemia   [ Time Frame: Baseline to Week 52 ]

4.  Secondary:   Proportion of Participants With Body Weight Reduction of at Least 5%   [ Time Frame: Baseline to Week 52 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats


  More Information