Dapagliflozin DPPIV Inhibitor add-on Study

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00984867
First received: September 23, 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, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Type 2 Diabetes
Interventions: Drug: Dapagliflozin
Drug: Placebo

  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
First participant enrolled: 10 Oct 2009. Last participant last visit for 24-week period: 10 Mar 2011. 833 participants were enrolled, 452 randomized and 451 treated in 3 European countries, USA, Argentina and Mexico. Participants with T2DM who showed inadequate glycemic control (7.0% ≤ HbA1c ≤ 10.0% at randomization) on sitagliptin +/- metformin.

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. Participants eligible for the study were stratified according to use of metformin.

Reporting Groups
  Description
Placebo Placebo plus sitagliptin alone or in combination with metformin
Dapagliflozin Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin

Participant Flow:   Overall Study
    Placebo     Dapagliflozin  
STARTED     226 [1]   225 [2]
COMPLETED     203     208  
NOT COMPLETED     23     17  
Adverse Event                 3                 7  
Death                 1                 0  
Withdrawal by Subject                 13                 4  
Lost to Follow-up                 3                 4  
Poor/non-compliance                 0                 1  
Subject no longer meets study criteria                 1                 1  
site closing                 1                 0  
lack of efficacy and subject compliance                 1                 0  
[1] Of the 226 randomized and treated participants only 224 were included in the full analysis set.
[2] Of the 225 randomized and treated participants only 223 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
Placebo Placebo plus sitagliptin alone or in combination with metformin
Dapagliflozin Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin
Total Total of all reporting groups

Baseline Measures
    Placebo     Dapagliflozin     Total  
Number of Participants  
[units: participants]
  224     223     447  
Age  
[units: Years]
Mean ± Standard Deviation
  55.0  ± 10.20     54.8  ± 10.42     54.9  ± 10.30  
Gender  
[units: participants]
     
Female     106     96     202  
Male     118     127     245  
HbA1c  
[units: HbA1c [%]]
Mean ± Standard Deviation
  7.97  ± 0.778     7.90  ± 0.806     7.93  ± 0.792  
Body weight  
[units: kg]
Mean ± Standard Deviation
  89.23  ± 20.887     91.02  ± 21.637     90.12  ± 21.259  
FPG  
[units: mg/dL]
Mean ± Standard Deviation
  162.97  ± 34.452     162.19  ± 36.825     162.58  ± 35.618  
Seated SBP in subjects with baseline seated SBP ≥130 mmHg  
[units: mmHg]
Mean ± Standard Deviation
  139.30  ± 8.507     140.46  ± 8.018     139.85  ± 8.279  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Adjusted Mean Change in HbA1c Levels   [ Time Frame: Baseline to Week 24 ]

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

3.  Secondary:   Adjusted Mean Change in HbA1c in Participants With Baseline HbA1c ≥8%   [ Time Frame: Baseline to Week 24 ]

4.  Secondary:   Adjusted Mean Change in Fasting Plasma Glucose (FPG)   [ Time Frame: Baseline to Week 24 ]

5.  Secondary:   Adjusted Mean Change in Seated Systolic Blood Pressure (SBP) in Participants With Baseline SBP>=130 mmHg   [ Time Frame: Baseline to Week 8 ]

6.  Secondary:   Adjusted Mean Change in 2-hour Post Liquid Meal Glucose Rise   [ Time Frame: Baseline to Week 24 ]

7.  Secondary:   Proportion of Participants Achieving a Therapeutic Glycemic Response Defined as a Reduction in HbA1c of ≥0.7% Compared to Baseline   [ Time Frame: Baseline to Week 24 ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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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 8 and/or 24 weeks, respectively, LOCF was used. All endpoints were evaluated by excluding data after rescue with the exception of systolic blood pressure which was evaluated regardless of rescue medication.  


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


No publications provided


Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00984867     History of Changes
Other Study ID Numbers: D1690C00010
Study First Received: September 23, 2009
Results First Received: January 21, 2013
Last Updated: August 9, 2013
Health Authority: United States: Food and Drug Administration