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

This study has been completed.
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: April 15, 2008
Last updated: March 10, 2015
Last verified: March 2015
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
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 1st patient was enrolled on 31 Mar 2008. The last patient last visit was on 15 Dec 2009. 1901 patients (pts) were screened and 1217 pts were enrolled with the aim to randomize 816. 2 randomized pts were excluded since they received no medication. Eventually, 814 pts received medication. This study was conducted at 95 centers world-wide.

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
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

  Outcome Measures
  Show All Outcome Measures

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
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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 52 weeks LOCF (last observation carried forward) was used.

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