A Trial of BMS-512148 in Patients with Type 2 Diabetes Mellitus
Study identifier:MB102-008
ClinicalTrials.gov identifier:NCT00263276
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2 Trial to Evaluate the Safety and Efficacy of BMS-512148 as Monotherapy in Subjects With Type 2 Diabetes Mellitus Who Are Treatment Naive And Have Inadequate Glycemic Control on Diet and Exercise
Medical condition
Type 2 Diabetes
Phase
Phase 2
Healthy volunteers
No
Study drug
dapagliflozin, placebo, metformin
Sex
All
Actual Enrollment
389
Study type
Interventional
Age
18 Years - 79 Years
Date
Study Start Date: 01 Dec 2005
Primary Completion Date: 01 Feb 2007
Study Completion Date: 01 Feb 2007
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Nov 2016 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
Bristol-Myers Squibb
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1 | Drug: dapagliflozin Tablets, Oral, 2.5 mg, Once daily, 12 weeks. |
| Experimental: Arm 2 | Drug: dapagliflozin Tablets, Oral, 5 mg, Once daily, 12 weeks. |
| Experimental: Arm 3 | Drug: dapagliflozin Tablets, Oral, 10 mg, Once daily, 12 weeks. |
| Experimental: Arm 4 | Drug: dapagliflozin Tablets, Oral, 20 mg, Once daily, 12 weeks. |
| Experimental: Arm 5 | Drug: dapagliflozin Tablets, Oral, 50 mg, Once daily, 12 weeks. |
| Placebo Comparator: Arm 6 | Drug: placebo Tablets, Oral, 0 mg, Once daily, 12 weeks. |
| Active Comparator: Arm 7 | Drug: metformin Tablets, Oral, >/= 1500 mg, Once daily, 12 weeks. |
Contacts
Contact
AstraZeneca Clinical Study Information Center Clinical Study Information Center
Investigators
Principal Investigator
Bristol Myers Squibb
Bristol Myers Squibb
