Insulin Glargine v Rosiglitazone as add-on Therapy in Patients Failing Sulfonylurea and Metformin Combination Therapy
This study has been completed.
Information provided by:
First received: July 28, 2006
Last updated: January 10, 2011
Last verified: January 2011
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
Type 2 Diabetes Mellitus
Drug: insulin glargine
|Study Design:||Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Resource links provided by NLM:
Drug Information available for: Metformin Metformin hydrochloride Insulin Insulin human Rosiglitazone Rosiglitazone Maleate Insulin glargineU.S. FDA Resources
Further study details as provided by Sanofi:
Primary Outcome Measures:
- 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:
- 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
|Study Start Date:||January 2001|
|Estimated Study Completion Date:||June 2002|
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