Study Assessing Saxagliptin Treatment In Type 2 Diabetic Subjects Who Are Not Controlled With Metformin Alone
Study identifier:CV181-014
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 III Trial to Evaluate the Efficacy and Safety of BMS-477118 in Combination with Metformin in Subjects with Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone"
Medical condition
Diabetes Mellitus, Type 2
Phase
Phase 3
Healthy volunteers
No
Study drug
Saxagliptin + Metformin, Placebo + Metformin, Pioglitazone
Sex
All
Actual Enrollment
1462
Study type
Interventional
Age
18 Years - 77 Years
Date
Study Start Date: 01 Aug 2005
Primary Completion Date: 01 Oct 2006
Study Completion Date: 01 Feb 2010
Study design
Allocation: Randomized
Endpoint Classification: Safety/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 + Metformin (A) Pioglitazone 15-45 mg (as needed for rescue) | Drug: Saxagliptin + Metformin Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT) Other Name: BMS-477118 Drug: Pioglitazone Tablets, Oral, 15 - 45 mg (as needed for rescue) |
| Experimental: Saxagliptin + Metformin (B) Pioglitazone 15-45 mg (as needed for rescue) | Drug: Saxagliptin + Metformin Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT) Other Name: BMS-477118 Drug: Pioglitazone Tablets, Oral, 15 - 45 mg (as needed for rescue) |
| Experimental: Saxagliptin + Metformin (C) Pioglitazone 15-45 mg (as needed for rescue) | Drug: Saxagliptin + Metformin Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT) Other Name: BMS-477118 Drug: Pioglitazone Tablets, Oral, 15 - 45 mg (as needed for rescue) |
| Placebo Comparator: Placebo+ Metformin (D) Pioglitazone 15-45 mg (as needed for rescue) | Drug: Placebo + Metformin Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT) Drug: Pioglitazone Tablets, Oral, 15 - 45 mg (as needed for rescue) |
