Primary objective: To determine the effect of Rimonabant 20mg on the co-primary endpoint including Fasting Plasma Glucose (FPG), HDL-Cholesterol (HDL-C) and triglyceride (TG) levels over a period of 12 months when prescribed with a mild hypocaloric diet in abdominally obese patients with impaired fasting blood glucose and with or without associated comorbidities. Main Secondary objectives: To determine the effect of 12 months Rimonabant treatment versus placebo on changes in waist circumference (WC), body weight, glycemic parameters and lipid parameters. To assess the safety of 12 months Rimonabant treatment versus placebo in these patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
2,666
Once daily in the morning
Once daily in the morning
Sanofi-Aventis Administrative Office
Vienna, Austria
Sanofi-Aventis Administrative Office
Diegem, Belgium
Sanofi-Aventis Administrative Office
São Paulo, Brazil
Sanofi-Aventis Administrative Office
Sofia, Bulgaria
Sanofi-Aventis Administrative Office
Laval, Canada
Sanofi-Aventis Administrative Office
Prague, Czechia
Sanofi-Aventis Administrative Office
Hørsholm, Denmark
Sanofi-Aventis Administrative Office
Cairo, Egypt
Sanofi-Aventis Administrative Office
Helsinki, Finland
Sanofi-Aventis Administrative Office
Paris, France
...and 17 more locations
Mean change in the co-primary endpoint : FPG, HDL-C and triglyceride levels.
Time frame: From baseline to end of treatment
Waist circumference and body weight
Time frame: At each visit
Glycemic parameters (FPG, fasting insulinemia, HbA1c), lipid parameters (Total Cholesterol, HDL-C, LDL-C, triglyceride levels), inflammatory parameter (Hs-CRP),
Time frame: All these laboratory parameters will be measured prior to baseline, month 3, month 6 and month 12.
Quality of life (IWQOL questionnaire completion)
Time frame: At baseline, month 3, month 6, month 9 and month 12
Incidence of adverse events in each group, including neuro-psychiatric adverse events
Time frame: From the signature of the ICF to the end of the study
Standard laboratory assessments
Time frame: Prior to baseline and month 12
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