The purpose of this study is to assess the effect of rimonabant treatment on the histological features of Nonalcoholic Steatohepatitis (NASH) in patients with Type 2 diabetes.
The total duration per patient will be approximately 22 months including a 18-month double-blind treatment period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
89
Tablet, oral administration
Tablet, oral administration
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States
Mean change per year in Non-Alcoholic Fatty Liver Disease [NAFLD] Activity Score (NAS)
Time frame: Baseline to 18 months
Change from baseline in hepatic fibrosis score
Time frame: Baseline to 18 months
Change from baseline in serum hyaluronate and hepatic transaminases (AST/ALT)
Time frame: Baseline to 18 months
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