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A Phase III Study of BMS-512148 (Dapagliflozin) in Asian Patients With Type 2 Diabetes Who Are Not Well Controlled on Metformin Alone

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca, Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01095666
First received: March 26, 2010
Last updated: September 4, 2017
Last verified: September 2017
Results First Received: October 3, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Type 2 Diabetes
Interventions: Drug: Dapagliflozin
Drug: Metformin
Drug: Dapagliflozin Placebo
Drug: Pioglitazone

  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
Of 1484 patients enrolled, 554 completed a qualification period. Of these 554 patients, 444 were randomized and received treatment. Of these 444 participants, 409 completed the double-blind treatment period

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Placebo + Metformin No text entered.
Dapagliflozin 5 mg + Metformin No text entered.
Dapagliflozin 10 mg + Metformin No text entered.

Participant Flow:   Overall Study
    Placebo + Metformin   Dapagliflozin 5 mg + Metformin   Dapagliflozin 10 mg + Metformin
STARTED   145   147   152 
COMPLETED   128   136   145 
NOT COMPLETED   17   11   7 
Lack of Efficacy                0                0                1 
Adverse Event                2                1                3 
Lost to Follow-up                2                2                0 
Withdrawal by Subject                6                6                1 
Non-compliance, not met criteria etc.                7                2                2 



  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.
All randomized participants who received at least 1 dose of study medication

Reporting Groups
  Description
Placebo + Metformin No text entered.
Dapagliflozin 5 mg + Metformin No text entered.
Dapagliflozin 10 mg + Metformin No text entered.
Total Total of all reporting groups

Baseline Measures
   Placebo + Metformin   Dapagliflozin 5 mg + Metformin   Dapagliflozin 10 mg + Metformin   Total 
Overall Participants Analyzed 
[Units: Participants]
 145   147   152   444 
Age 
[Units: Years]
Mean (Standard Deviation)
 53.5  (9.20)   53.1  (9.09)   54.6  (9.54)   53.8  (9.29) 
Age, Customized 
[Units: Participants]
       
Yonger than 65 years   129   132   126   387 
65 to younger than 75 years   14   13   25   52 
75 years and older   2   2   1   5 
Sex/Gender, Customized 
[Units: Participants]
       
Male   86   67   88   241 
Female   59   80   64   203 
Race/Ethnicity, Customized 
[Units: Participants]
       
Asian Indian   10   11   13   34 
Chinese   126   127   129   382 
Korean   9   9   10   28 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF])   [ Time Frame: From Baseline to Week 24 ]

2.  Secondary:   Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF])   [ Time Frame: From Baseline to Week 24 ]

3.  Secondary:   Adjusted Mean Change From Baseline in 2-hour Post Meal Glucose (PMG) (mg/dL) at Week 24 (Last Observation Carried Forward [LOCF])   [ Time Frame: From Baseline to Week 24 ]

4.  Secondary:   Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF])   [ Time Frame: From Baseline to Week 24 ]

5.  Secondary:   Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])   [ Time Frame: From Baseline to Week 24 ]


  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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Anna Maria Langkilde
Organization: AstraZeneca
e-mail: ClinicalTrialTransparency@astrazeneca.com



Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01095666     History of Changes
Other Study ID Numbers: MB102-055
Study First Received: March 26, 2010
Results First Received: October 3, 2016
Last Updated: September 4, 2017