A Phase III Study of BMS-512148 (Dapagliflozin) in Asian Patients With Type 2 Diabetes Who Are Not Well Controlled on Metformin Alone
Study identifier:MB102-055
ClinicalTrials.gov identifier:NCT01095666
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
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
Medical condition
Type 2 Diabetes
Phase
Phase 3
Healthy volunteers
No
Study drug
Dapagliflozin, Metformin, Dapagliflozin Placebo, Pioglitazone
Sex
All
Actual Enrollment
1484
Study type
Interventional
Age
18 Years +
Date
Study Start Date: 01 Jun 2010
Primary Completion Date: 01 Mar 2013
Study Completion Date: 01 Mar 2013
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Aug 2017 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
AstraZeneca, Bristol-Myers Squibb
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Group 1 | Drug: Dapagliflozin Tablets, Oral, 5 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 2 | 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 3 | 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 |
Contacts
Investigators
Principal Investigator
Bristol-Myers Squibb
Bristol-Myers Squibb
