Safety and Efficacy of Saxagliptin Plus Insulin With or Without Metformin
Study identifier:CV181-057
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Multicenter, Randomized, Double-Blind, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin Added to Insulin Monotherapy or to Insulin in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Insulin Alone or on Insulin in Combination With Metformin
Medical condition
Type 2 Diabetes
Phase
Phase 3
Healthy volunteers
No
Study drug
Saxagliptin, 5 mg + insulin, Placebo + insulin
Sex
All
Actual Enrollment
455
Study type
Interventional
Age
18 Years - 78 Years
Date
Study Start Date: 01 Nov 2008
Primary Completion Date: 01 Apr 2010
Study Completion Date: 01 Apr 2010
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 May 2015 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
AstraZeneca
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Saxagliptin, 5 mg + insulin Saxagliptin, 5 mg, plus insulin, administered to participants with Type 2 diabetes inadequately controlled with insulin alone or with insulin plus metformin | Drug: Saxagliptin, 5 mg + insulin Saxagliptin, 5-mg tablets (plus stable insulin dose), given orally once daily (24 weeks short-term, 28 weeks long-term); participants stratified by use of stable metformin dose; flexible insulin dose (as needed for rescue) Other Name: BMS-477118 |
| Placebo Comparator: Placebo + insulin Placebo administered to participants with Type 2 diabetes inadequately controlled with insulin alone or with insulin plus metformin | Drug: Placebo + insulin Placebo tablets given orally once daily for 24 weeks (short-term period)+ insulin with metformin |
Contacts
Investigators
Principal Investigator
Bristol-Myers Squibb
Bristol-Myers Squibb
