Evaluation of the Effect of Dapagliflozin in Combination With Metformin on Body Weight in Subjects With Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00855166
First received: March 3, 2009
Last updated: August 9, 2013
Last verified: August 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, Investigator);   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: Dapagliflozin
Drug: Metformin
Drug: Sitagliptin
Drug: Placebo

  Participant Flow
  Hide Participant Flow

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: 13 Feb 2009. Last participant completed 24 week period: 03 Jun 2010. 314 participants were enrolled, 182 were randomized in 40 centers in 5 European countries. Men aged 30-75 years and women aged 55-75 years with inadequate glycemic control (HbA1c 6.5% to 8.5%), BMI of at least 25 kg/sqm and body weight <= 120 kg.

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. The metformin dose was adjusted to open label 1500 mg/day, 2000 mg/day or 2500 mg/day. Neither gender should exceed 60% of the total number of randomized participants.

Reporting Groups
  Description
Placebo Plus Metformin Placebo oral once daily plus metformin over 24 weeks
Dapagliflozin Plus Metformin Dapagliflozin 10 mg oral once daily plus metformin over 24 weeks

Participant Flow:   Overall Study
    Placebo Plus Metformin     Dapagliflozin Plus Metformin  
STARTED     91     91 [1]
COMPLETED     86     83  
NOT COMPLETED     5     8  
Adverse Event                 0                 2  
Death                 0                 1  
Withdrawal by Subject                 1                 4  
Poor/non-compliance                 2                 0  
Administrative reasons by sponsor                 1                 0  
Subject no longer meets study criteria                 1                 1  
[1] Of the 91 randomized participants only 89 were included in the full analysis set.



  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
Placebo Plus Metformin Placebo oral once daily plus metformin over 24 weeks
Dapagliflozin Plus Metformin Dapagliflozin 10 mg oral once daily plus metformin over 24 weeks
Total Total of all reporting groups

Baseline Measures
    Placebo Plus Metformin     Dapagliflozin Plus Metformin     Total  
Number of Participants  
[units: participants]
  91     89     180  
Age  
[units: Years]
Mean ± Standard Deviation
  60.8  ± 6.82     60.6  ± 8.16     60.7  ± 7.49  
Gender  
[units: Participants]
     
Female     40     40     80  
Male     51     49     100  
Race/Ethnicity, Customized  
[units: Participants]
     
White     91     89     180  
Body Weight  
[units: Kilogram]
Mean ± Standard Deviation
  90.91  ± 13.716     92.06  ± 14.128     91.48  ± 13.894  
Body Mass Index  
[units: kg/m2]
Mean ± Standard Deviation
  31.68  ± 3.890     32.06  ± 3.887     31.87  ± 3.882  
Glycosylated hemoglobin A1c (HbA1c)  
[units: Percent]
Mean ± Standard Deviation
  7.16  ± 0.531     7.19  ± 0.443     7.17  ± 0.489  
Fasting Plasma Glucose  
[units: Milligram┬áper┬ádeciliter]
Mean ± Standard Deviation
  149.60  ± 25.086     148.01  ± 24.650     148.82  ± 24.815  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Adjusted Mean Change in Total Body Weight   [ Time Frame: Baseline to Week 24 ]

2.  Secondary:   Adjusted Mean Change in Waist Circumference   [ Time Frame: Baseline to Week 24 ]

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

4.  Secondary:   Proportion of Participants With Body Weight Decrease ≥5%   [ Time Frame: Baseline to Week 24 ]

5.  Other Pre-specified:   Adjusted Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-4)   [ Time Frame: Baseline to Week 102 ]

6.  Other Pre-specified:   Adjusted Percent Change in Bone Mineral Density (BMD) at Femoral Neck   [ Time Frame: Baseline to Week 102 ]

7.  Other Pre-specified:   Adjusted Percent Change in Bone Mineral Density (BMD) at Total Hip   [ Time Frame: Baseline to Week 102 ]


  Serious Adverse Events


  Other Adverse Events


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
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 24 weeks, last observation carried forward (LOCF) was used.  


Results Point of Contact:  
Name/Title: Eva Johnsson
Organization: AstraZeneca
e-mail: ClinicalTrialTransparency@astrazeneca.com


No publications provided by AstraZeneca

Publications automatically indexed to this study:

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00855166     History of Changes
Other Study ID Numbers: D1690C00012
Study First Received: March 3, 2009
Results First Received: January 21, 2013
Last Updated: August 9, 2013
Health Authority: Bulgaria: Bulgarian Drug Agency
Czech Republic: State Institute for Drug Control
Hungary: National Institute of Pharmacy
Poland: Ministry of Health
Sweden: Medical Products Agency