A Study Assessing Saxagliptin Treatment in Type 2 Diabetic Subjects Who Are Not Controlled With TZD Therapy Alone
Study identifier:CV181-013
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 Saxagliptin (BMS477118) in Combination with Thiazolidinedione Therapy in Subjects with Type 2 Diabetes Who Have Inadequate Glycemic Control on Thiazolidinedione Therapy Alone
Medical condition
Diabetes Mellitus, Type 2
Phase
Phase 3
Healthy volunteers
No
Study drug
Saxagliptin, Placebo, pioglitazone, rosiglitazone, metformin
Sex
All
Actual Enrollment
565
Study type
Interventional
Age
18 Years - 77 Years
Date
Study Start Date: 01 Mar 2006
Primary Completion Date: 01 Oct 2007
Study Completion Date: 01 Oct 2008
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 plus open-label TZD (A) Saxagliptin PLUS pioglitazone OR rosiglitazone PLUS open-label metformin (as needed as rescue medication) | Drug: Saxagliptin Tablets, Oral, 2.5 mg, Once daily (6 months ST, 12 months LT) Other Name: BMS-477118 Drug: pioglitazone Tablets, Oral, 30 mg or 45 mg, once daily (6 months ST, 12 months LT) Drug: rosiglitazone Tablets, Oral, 4 mg, once daily or 8 mg, either as once or twice daily (6 months ST, 12 months LT) Drug: metformin Tablets, Oral, 500-2500 mg, as needed (12 months LT) |
| Experimental: Saxagliptin plus open-label TZD (B) Saxagliptin PLUS pioglitazone OR rosiglitazone PLUS open-label metformin (as needed as rescue medication) | Drug: Saxagliptin Tablets, Oral, 5 mg, once daily (6 months ST, 12 months LT) Other Name: BMS-477118 Drug: pioglitazone Tablets, Oral, 30 mg or 45 mg, once daily (6 months ST, 12 months LT) Drug: rosiglitazone Tablets, Oral, 4 mg, once daily or 8 mg, either as once or twice daily (6 months ST, 12 months LT) Drug: metformin Tablets, Oral, 500-2500 mg, as needed (12 months LT) |
| Placebo Comparator: Placebo plus open-label TZD (C) Placebo PLUS pioglitazone OR rosiglitazone PLUS open-label metformin (as needed as rescue medication) | Drug: Placebo Tablets, Oral, 0 mg, Once daily (6 months ST, 12 months LT) Drug: pioglitazone Tablets, Oral, 30 mg or 45 mg, once daily (6 months ST, 12 months LT) Drug: rosiglitazone Tablets, Oral, 4 mg, once daily or 8 mg, either as once or twice daily (6 months ST, 12 months LT) Drug: metformin Tablets, Oral, 500-2500 mg, as needed (12 months LT) |
Contacts
Investigators
Principal Investigator
Bristol-Myers Squibb
Bristol-Myers Squibb
