Insulin Glargine v Rosiglitazone as add-on Therapy in Patients Failing Sulfonylurea and Metformin Combination Therapy
Phase 4
Completed
- Conditions
- Type 2 Diabetes Mellitus
- Registration Number
- NCT00358124
- Lead Sponsor
- Sanofi
- Brief Summary
To compare the glycemic control, as measured by HbA1C, between insulin glargine and rosiglitazone add-on therapies in patients who fail oral combination of a sulfonylurea and metformin
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 220
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The primary efficacy variable was the change in HbA1C from baseline to the end of therapy. Other efficacy variables were the change from baseline in FPG, serum lipids and weight.
- Secondary Outcome Measures
Name Time Method Secondary efficacy parameters were: a mean change from baseline in FPG Mean change from baseline in fasting insulin/C-peptide levels Mean change from baseline in lipid levels (total cholesterol, HDL, LDL, TG, free fatty acids) Mean change from baseline for bodyweight. Health-related quality of life was compared between the baseline visit and the follow-up assessments
Trial Locations
- Locations (1)
Sanofi-Aventis
🇺🇸Bridgewater, New Jersey, United States