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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: 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


  Baseline Characteristics
  Hide Baseline Characteristics

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 
Overall Participants Analyzed 
[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
  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.


  More Information