A Phase IIA study of BMS-512148 to assess safety, exposure, and biological effects in stable Type 2 diabetic subjects
Study identifier:MB102-003
ClinicalTrials.gov identifier:NCT00162305
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A double-blind, placebo-controlled, randomized, multiple-dose study to evaluate the safety, pharmacokinetics, and pharmacodynamics of bms-512148 in diabetic subjects
Medical condition
Diabetes Mellitus, Type 2
Phase
Phase 2
Healthy volunteers
No
Study drug
BMS-512148, Placebo
Sex
All
Actual Enrollment
47
Study type
Interventional
Age
18 Years - 70 Years
Date
Study Start Date: 01 Apr 2005
Primary Completion Date: 01 Aug 2005
Study Completion Date: 01 Aug 2005
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Oct 2016 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
Bristol-Myers Squibb
Inclusion and exclusion criteria
Loading...
No locations available
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 1 | Drug: BMS-512148 Capsules, Oral, 100 mg, Once daily, 14 days. Other Name: Dapagliflozin |
| Active Comparator: 2 | Drug: BMS-512148 Capsules, Oral, 25 mg, Once daily, 14 days. Other Name: Dapagliflozin |
| Active Comparator: 3 | Drug: BMS-512148 Capsules, Oral, 5 mg, Once daily, 14 days. Other Name: Dapagliflozin |
| Placebo Comparator: 4 | Drug: Placebo Capsules, Oral, 0 mg, Once daily, 14 days. Other Name: Dapagliflozin |
Contacts
Contact
AstraZeneca Clinical Study Information Center Clinical Study Information Center
Investigators
Principal Investigator
Bristol Myers Squibb
Bristol Myers Squibb
