Study of dapagliflozin in combination with metformin XR to initiate the treatment of type 2 diabetes
Study identifier:MB102-034
ClinicalTrials.gov identifier:NCT00859898
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Multicenter, Randomized, Double-Blind, Active Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin 10 mg in Combination with Metformin as Initial Therapy as Compared with Dapagliflozin 10 mg Monotherapy and Metformin Monotherapy in Subjects with Type 2 Diabetes Who Have Inadequate Glycemic Control
Medical condition
Type 2 Diabetes Mellitus
Phase
Phase 3
Healthy volunteers
No
Study drug
Dapagliflozin, Metformin XR, dapagliflozin matching Placebo, metformin HCl Modified Release matching Placebo
Sex
All
Actual Enrollment
1093
Study type
Interventional
Age
18 Years - 77 Years
Date
Study Start Date: 01 Apr 2009
Primary Completion Date: 01 May 2010
Study Completion Date: 01 May 2010
Study design
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 May 2016 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
Bristol-Myers Squibb
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Dapagliflozin + Metformin XR Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks | Drug: Dapagliflozin Tablets, Oral, 10 mg, once daily, 24 weeks Other Name: Farxiga™ Drug: Metformin XR Tablets, Oral, up to 2000 mg, once daily, 24 weeks Other Name: Glucophage® |
| Experimental: Dapagliflozin + Placebo Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks. Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks. | Drug: Dapagliflozin Tablets, Oral, 10 mg, once daily, 24 weeks Other Name: Farxiga™ Drug: metformin HCl Modified Release matching Placebo Tablets |
| Active Comparator: Metformin XR + Placebo Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks | Drug: Metformin XR Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks Other Name: Glucophage® Drug: dapagliflozin matching Placebo Tablets |
Contacts
Contact
AstraZeneca Clinical Study Information Center AstraZeneca Clinical Study Information Center
Investigators
Principal Investigator
Bristol-Myers Squibb
Bristol-Myers Squibb
