NCT00358124
Completed
Phase 4
Insulin Glargine v Rosiglitazone as add-on Therapy in Patients Failing Sulfonylurea and Metformin Combination Therapy
Overview
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Sanofi
- Enrollment
- 220
- Locations
- 1
- Primary Endpoint
- The primary efficacy variable was the change in HbA1C from baseline to the end of therapy.
Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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 Outcomes
- 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
Investigators
Study Sites (1)
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