Diabetes Mellitus, Type 2 Clinical Trial
Official title:
A Multicenter, Double Blind, Placebo Controlled Randomized Study of the Efficacy and Safety of Two Rimonabant/Metformin Combinations for Reducing A1C in the Treatment of Patients With Type 2 Diabetes Mellitus Who Are Not on Current Drug Therapy.
The primary objective of the study is to demonstrate superiority of rimonabant/metformin
combinations in A1C reduction over the corresponding single agent metformin and over
rimonabant alone in patients with type 2 diabetes mellitus at 9 months.
The secondary objective of the study is to investigate the effects of rimonabant/metformin
combinations for reducing fasted plasma glucose, body weight and triglycerides, and raising
HDL-C in comparison with metformin at 9 months.
Another study objective is to evaluate the safety of rimonabant in combination with
metformin over a period of up to 52 weeks.
The duration per patient is up to 65 weeks: 1 - 2 weeks screening, up to 52 weeks double blind treatment, and 75 days post last dose. This study will end for all patients when the last patient has been treated for at least 9 months. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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