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A Phase III Study of BMS-512148 (Dapagliflozin) in Asian Patients With Type 2 Diabetes Who Are Not Well Controlled With Diet and Exercise

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ClinicalTrials.gov Identifier: NCT01095653
Recruitment Status : Completed
First Posted : March 30, 2010
Results First Posted : February 6, 2017
Last Update Posted : February 6, 2017
Sponsor:
Collaborator:
AstraZeneca, Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca

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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Of 1179 participants enrolled, 514 completed a qualification period. Of these 514 participants, 393 were randomized and received treatment. Of these 393 participants, 343 completed double-blind treatment period.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo Participants received dapagliflozin matching placebo once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
Dapagliflozin 5 mg Participants received dapagliflozin 5 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
Dapagliflozin 10 mg Participants received dapagliflozin 10 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)

Participant Flow:   Overall Study
    Placebo   Dapagliflozin 5 mg   Dapagliflozin 10 mg
STARTED   132   128   133 
COMPLETED   113   113   117 
NOT COMPLETED   19   15   16 
Lack of Efficacy                3                0                0 
Adverse Event                1                4                4 
Lost to Follow-up                1                0                4 
Withdrawal by Subject                4                5                3 
non-compliance, not met criteria, etc.                10                6                5 



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

Reporting Groups
  Description
Placebo Participants received dapagliflozin matching placebo once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
Dapagliflozin 5 mg Participants received dapagliflozin 5 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
Dapagliflozin 10 mg Participants received dapagliflozin 10 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
Total Total of all reporting groups

Baseline Measures
   Placebo   Dapagliflozin 5 mg   Dapagliflozin 10 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 132   128   133   393 
Age 
[Units: Years]
Mean (Standard Deviation) 		 49.9  (10.87)   53.0  (11.07)   51.2  (9.89)   51.3  (10.67) 
Age, Customized 
[Units: Participants]
 		       
Younger than 65 years   120   108   123   351 
65 to younger than 75 years   11   14   10   35 
75 years and older   1   6   0   7 
Gender, Customized 
[Units: Participants]
 		       
Male   87   84   86   257 
Female   45   44   47   136 
Race/Ethnicity, Customized 
[Units: Participants]
 		       
ASIAN INDIAN   8   8   9   25 
CHINESE   117   114   117   348 
JAPANESE   1   0   1   2 
KOREAN   5   6   5   16 
ASIAN OTHER   1   0   1   2 
Weight 
[Units: Kg]
Mean (Standard Deviation) 		 72.18  (13.234)   68.89  (11.429)   70.92  (11.637)   70.68  (12.177) 
Body Mass Index (BMI) 
[Units: Kg/m^2]
Mean (Standard Deviation) 		 25.93  (3.644)   25.17  (3.285)   25.76  (3.434)   25.62  (3.465) 


  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 ]
  Show Outcome Measure 1

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 ]
  Show Outcome Measure 2

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

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 ]
  Show Outcome Measure 4

5.  Secondary:   Percentage of 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 ]
  Show Outcome Measure 5


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.


  More Information

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: NCT01095653     History of Changes
Other Study ID Numbers: MB102-054
First Submitted: March 26, 2010
First Posted: March 30, 2010
Results First Submitted: September 30, 2016
Results First Posted: February 6, 2017
Last Update Posted: February 6, 2017