Study To Evaluate 24 Hour Blood Sugar Control (24-hour mean weighted glucose) In Subjects That Are Taking Saxagliptin 5 mg Added Onto Metformin XR 1500 XR mg Compared To Subjects Taking Metformin XR 1500 mg Up-titrated To Metformin XR 2000 mg
Study identifier:CV181-085
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A 4-Week, Multicenter, Randomized, Double-Blind, Phase 3b Trial to Evaluate the Efficacy of Saxagliptin in Combination with Metformin XR 1500 mg versus up-titrated Metformin XR to 2000 mg in Subjects with Type 2 Diabetes Who Have Inadequate Glycemic Control with Diet and Exercise and a Stable Dose of Metformin XR 1500 mg
Medical condition
Type 2 Diabetes
Phase
Phase 3
Healthy volunteers
No
Study drug
Saxagliptin, Metformin XR, Placebo matching Metformin XR, Placebo matching Saxagliptin
Sex
All
Actual Enrollment
219
Study type
Interventional
Age
18 Years - 78 Years
Date
Study Start Date: 01 Aug 2009
Primary Completion Date: 01 May 2010
Study Completion Date: 01 May 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
Astra Zeneca
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Saxagliptin + Metformin XR + matching Metformin XR placebo (Saxagliptin 5 mg plus Metformin XR 1500 plus matching Metformin XR 500 mg placebo) | Drug: Saxagliptin Tablets, Oral, 5 mg, once daily, 4 weeks Other Name: BMS-477118 Other Name: Onglyza Drug: Metformin XR Tablets, Oral, 1500 mg, once daily, 4 weeks Other Name: Glucophage XR® Drug: Placebo matching Metformin XR Tablets, Oral, 0 mg, once daily, 4 weeks |
| Active Comparator: Metformin XR + Metformin XR + matching Saxagliptin placebo (Metformin XR 500 mg plus Metformin XR 1500 mg plus matching Saxagliptin 5 mg placebo) | Drug: Metformin XR Tablets, Oral, 1500 mg, once daily, 4 weeks Other Name: Glucophage XR® Drug: Metformin XR Tablets, Oral, 500 mg, once daily, 4 weeks Other Name: Glucophage XR® Drug: Placebo matching Saxagliptin Tablets, Oral, 0 mg, once daily, 4 weeks |
Contacts
Investigators
Principal Investigator
Bristol-Myers Squibb
Bristol-Myers Squibb
