A Phase 3 Study of BMS-477118 in combination with metformin in subjects with type 2 diabetes who are not controlled with diet and exercise
Study identifier:CV181-039
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Multicenter, Randomized, Double-Blind Active-Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin in Combination with Metformin IR as Initial Therapy Compared to Saxagliptin Monotherapy and to Metformin IR Monotherapy in Subjects with Type 2 Diabetes Who Have Inadequate Glycemic Control
Medical condition
diabetes
Phase
Phase 3
Healthy volunteers
No
Study drug
Saxagliptin, Metformin, Placebo, pioglitazone
Sex
All
Actual Enrollment
1306
Study type
Interventional
Age
18 Years - 77 Years
Date
Study Start Date: 01 May 2006
Primary Completion Date: 01 Nov 2007
Study Completion Date: 01 Dec 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 and Metformin (A) PLUS open-label pioglitazone (as needed as rescue medication) | Drug: Saxagliptin Coated Tablets, Oral, 10 mg, Daily (6 months ST, 12 months LT) Other Name: BMS-477118 Drug: Metformin Coated tablets, Oral, 500 mg, Daily (6 months ST, 12 months LT) Drug: pioglitazone Tablets, Oral, 15-45 mg, as needed (12 months LT) |
| Experimental: Saxagliptin and Metformin (B) PLUS open-label pioglitazone (as needed as rescue medication) | Drug: Saxagliptin Coated tablets, PO, 5 mg, Daily (6 months ST, 12 months LT) Other Name: BMS-477118 Drug: Metformin Coated tablets, Oral, 500 mg, Daily (6 months ST, 12 months LT) Drug: pioglitazone Tablets, Oral, 15-45 mg, as needed (12 months LT) |
| Experimental: Saxagliptin and Placebo (C) PLUS open-label pioglitazone (as needed as rescue medication) | Drug: Saxagliptin Coated Tablets, Oral, 10 mg, Daily (6 months ST, 12 months LT) Other Name: BMS-477118 Drug: Placebo Coated tablets, Oral, 0 mg, Daily (6 months ST, 12 months LT) Drug: pioglitazone Tablets, Oral, 15-45 mg, as needed (12 months LT) |
| Active Comparator: Metformin and Placebo (D) PLUS open-label pioglitazone (as needed as rescue medication) | Drug: Metformin Coated tablets, Oral, 500 mg, Daily (6 months ST, 12 months LT) Drug: Placebo Coated tablets, Oral, 0 mg, Daily (6 months ST, 12 months LT) Drug: pioglitazone Tablets, Oral, 15-45 mg, as needed (12 months LT) |
Contacts
Investigators
Principal Investigator
Bristol-Myers Squibb
Bristol-Myers Squibb
