Study of BMS-477118 as Monotherapy with Titration in Subjects with Type 2 Diabetes Who Are Not Controlled with Diet and Exercise
Study identifier:CV181-038
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin as Monotherapy with Titration in Subjects with Type 2 Diabetes Who Have Inadequate Glycemic Control with Diet and Exercise
Medical condition
diabetes
Phase
Phase 3
Healthy volunteers
No
Study drug
Saxagliptin, Placebo, metformin
Sex
All
Actual Enrollment
365
Study type
Interventional
Age
18 Years - 77 Years
Date
Study Start Date: 01 Jun 2006
Primary Completion Date: 01 Nov 2007
Study Completion Date: 01 Nov 2008
Study design
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Mar 2015 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Saxagliptin 2.5 mg QAM (A) PLUS open-label metformin (as needed as rescue medication) | Drug: Saxagliptin Coated tablets, Oral, 2.5 mg, QAM, Daily (6 months ST, 12 months LT) Other Name: BMS-477118 Drug: metformin Tablets, Oral, 500-2000 mg, as needed (12 months LT) |
| Experimental: Saxagliptin 2.5 mg titrated to 5 mg QAM (B) PLUS open-label metformin (as needed as rescue medication) | Drug: Saxagliptin Coated tablets, Oral, 2.5 mg titrated to 5mg, QAM, Daily (6 months ST, 12 months LT) Other Name: BMS-477118 Drug: metformin Tablets, Oral, 500-2000 mg, as needed (12 months LT) |
| Experimental: Saxagliptin 5 mg QAM (C) PLUS open-label metformin (as needed as rescue medication) | Drug: Saxagliptin Coated tablets, Oral, 5mg, QAM, Daily, (6 months ST, 12 months LT) Other Name: BMS-477118 Drug: metformin Tablets, Oral, 500-2000 mg, as needed (12 months LT) |
| Experimental: Saxagliptin 5 mg QPM (D) PLUS open-label metformin (as needed as rescue medication) | Drug: Saxagliptin Coated tablets, Oral, 5mg QPM, Daily (6 months ST, 12 months LT) Other Name: BMS-477118 Drug: metformin Tablets, Oral, 500-2000 mg, as needed (12 months LT) |
| Placebo Comparator: Placebo (E) PLUS open-label metformin (as needed as rescue medication) | Drug: Placebo Coated tablets, Oral, 0mg, Daily (6 months ST, 12 months LT) Drug: metformin Tablets, Oral, 500-2000 mg, as needed (12 months LT) |
Contacts
Investigators
Principal Investigator
Bristol-Myers Squibb
Bristol-Myers Squibb
