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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:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01095666
First received: March 26, 2010
Last updated: June 6, 2014
Last verified: June 2014

March 26, 2010
June 6, 2014
June 2010
March 2013   (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 NCT01095666 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 on Metformin Alone
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Combination With Metformin in Asian Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone

The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can help reduce the blood sugar levels in Asian patients with Type 2 Diabetes who are not well controlled on metformin alone. 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, 1500-3000 mg, Twice daily, 24 weeks
    Other Name: Glucophage®
  • Drug: Dapagliflozin Placebo
    Tablets, Oral, 0 mg, Once daily, 24 weeks
  • Drug: Pioglitazone
    Tablets, Oral, 15-45 mg (as needed for rescue based on protocol specific criteria), Up to 20 weeks
  • Experimental: Group 1
    Interventions:
    • Drug: Dapagliflozin
    • Drug: Metformin
    • Drug: Dapagliflozin Placebo
    • Drug: Pioglitazone
  • Experimental: Group 2
    Interventions:
    • Drug: Dapagliflozin
    • Drug: Metformin
    • Drug: Dapagliflozin Placebo
    • Drug: Pioglitazone
  • Experimental: Group 3
    Interventions:
    • Drug: Metformin
    • Drug: Dapagliflozin Placebo
    • Drug: Pioglitazone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
445
March 2013
March 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Males and females, 18 to 77 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
 
NCT01095666
MB102-055
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