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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
220
Sanofi-Aventis
Bridgewater, New Jersey, United States
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 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
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