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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01095653
First received: March 26, 2010
Last updated: June 6, 2014
Last verified: June 2014

March 26, 2010
June 6, 2014
June 2010
March 2012   (final data collection date for primary outcome measure)
Change from baseline in HbA1c for each dose of dapagliflozin vs placebo [ Time Frame: At Week 24 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01095653 on ClinicalTrials.gov Archive Site
  • Change from baseline in Fasting Plasma Glucose (FPG) [ Time Frame: At Week 24 ] [ Designated as safety issue: No ]
  • Change from baseline in 2hr-post meal glucose [ Time Frame: At Week 24 ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving a therapeutic glycemic response, defined as HbA1c < 7.0% [ Time Frame: At Week 24 ] [ Designated as safety issue: No ]
  • Change from baseline in total body weight [ Time Frame: At Week 24 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Phase III Study of BMS-512148 (Dapagliflozin) in Asian Patients With Type 2 Diabetes Who Are Not Well Controlled With Diet and Exercise
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin as Monotherapy in Asian Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise

The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can improve (decrease) blood glucose values in Asian patients with Type 2 Diabetes who have never been treated with medication or have been on medication for less than 24 weeks since their original diagnosis of Diabetes. The safety of this treatment will also be studied.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type 2 Diabetes
  • Drug: Dapagliflozin
    Tablets, Oral, 5 mg, Once daily, 24 weeks
    Other Name: BMS-512148
  • Drug: Dapagliflozin
    Tablets, Oral, 10 mg, Once daily, 24 weeks
    Other Name: BMS-512148
  • Drug: Metformin
    Tablets, Oral, 500-2000 mg (as needed for rescue based on protocol specific criteria), Up to 20 weeks
    Other Name: Glucophage®
  • Drug: Dapagliflozin Placebo
    Tablets, Oral, 0 mg, Once daily, 24 weeks
  • Experimental: Group 1
    Interventions:
    • Drug: Dapagliflozin
    • Drug: Metformin
    • Drug: Dapagliflozin Placebo
  • Experimental: Group 2
    Interventions:
    • Drug: Dapagliflozin
    • Drug: Metformin
    • Drug: Dapagliflozin Placebo
  • Experimental: Group 3
    Interventions:
    • Drug: Metformin
    • Drug: Dapagliflozin Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
393
March 2012
March 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Males and females, 18 years old, with type 2 diabetes and with inadequate glycemic control
  • Drug naive or treated with anti-diabetic medication for < 24 weeks
  • C-peptide ≥ 1.0 ng/mL
  • Body Mass Index ≤ 45.0 kg/m²

Exclusion Criteria:

  • AST and/or ALT > 3 times ULN
  • Serum total bilirubin > 2 mg/dL
  • Serum creatinine ≥ 1.50 mg/dL for men or ≥ 1.40 mg/dL for women
  • Creatine kinase ≥ 3 times ULN
  • Symptoms of severely uncontrolled diabetes
  • Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China,   India,   Korea, Republic of,   Taiwan
 
NCT01095653
MB102-054
Yes
AstraZeneca
AstraZeneca
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
AstraZeneca
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP