Saxagliptin Treatment in Subjects with Type 2 Diabetes Who Are Not Controlled with Diet and Exercise
Study identifier:CV181-011
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 (BMS-477118) as Monotherapy in Subjects with Type 2 Diabetes Who Have Inadequate Glycemic Control with Diet and Exercise
Medical condition
Diabetes Mellitus, Type 2
Phase
Phase 3
Healthy volunteers
No
Study drug
Saxagliptin, Placebo matching Saxagliptin, Metformin, Placebo matching Metformin
Sex
All
Actual Enrollment
1035
Study type
Interventional
Age
18 Years - 77 Years
Date
Study Start Date: 01 Jul 2005
Primary Completion Date: 01 Aug 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 2.5 mg (A) Metformin 500-2000 mg (as needed for rescue) | Drug: Saxagliptin Tablets, Oral, 2.5 mg, Once daily (24 weeks short term [ST], 42 months long term [LT]) Other Name: BMS-477118 Drug: Placebo matching Metformin Tablets, Oral, 0 mg, daily (42 months LT) Drug: Metformin Tablets, Oral, 500-2000 mg (as needed for rescue) |
| Experimental: Saxagliptin 5 mg (B) Metformin 500-2000 mg (as needed for rescue) | Drug: Saxagliptin Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT) Other Name: BMS-477118 Drug: Placebo matching Metformin Tablets, Oral, 0 mg, daily (42 months LT) Drug: Metformin Tablets, Oral, 500-2000 mg (as needed for rescue) |
| Experimental: Saxagliptin 10 mg (C) Metformin 500-2000 mg (as needed for rescue) | Drug: Saxagliptin Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT) Other Name: BMS-477118 Drug: Placebo matching Metformin Tablets, Oral, 0 mg, daily (42 months LT) Drug: Metformin Tablets, Oral, 500-2000 mg (as needed for rescue) |
| Placebo Comparator: Placebo (D) Metformin 500-2000 mg (as needed for rescue) | Drug: Placebo matching Saxagliptin Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT) Drug: Metformin Tablets, Oral, 500 mg, daily (42 months LT) Drug: Metformin Tablets, Oral, 500-2000 mg (as needed for rescue) |
| Experimental: Open-Label Treatment Cohort (Direct Enrollees) (E) Saxagliptin 10 mg Metformin 500-2000 mg (as needed for rescue) | Drug: Saxagliptin Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT) Open Label Other Name: BMS-477118 Drug: Metformin Tablets, Oral, 500-2000 mg (as needed for rescue) |
