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About
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.
Enrollment
Sex
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Inclusion criteria
Exclusion criteria
Pregnant or breast-feeding women, or women planning to become pregnant or breastfeed (excluded by pregnancy test),
Absence of medically approved contraceptive methods for female of childbearing potential,
History of very low-calorie diet within 3 months prior to screening visit (lower than 1200 Kcal/day),
Weight change > 5 kg within 3 months prior to screening visit,
History of surgical procedures for weight loss (e.g., stomach stapling, bypass),
History of bulimia or anorexia nervosa as per DSM-IV criteria,
Presence of any clinically significant endocrine disease according to the investigator, in particular known abnormal TSH and free T4 blood level (Patients treated with thyroid replacement therapy must be on fixed and stable dose for at least 3 months prior to screening and must be in euthyroïd status),
Established type 1 or 2 diabetes treated, or with at least 2 measures of fasting blood glucose ≥ 126 mg/dl /L,
Triglyceride level > 400 mg/dL (4.52 mmol),
Systolic blood pressure > 160 mm Hg or diastolic blood pressure >100 mmHg at screening visit,
Known severe renal dysfunction (creatinine clearance < 30 ml/min) or nephrotic syndrome or urinalysis (performed at screening by dipstick) showing 2+ or more protein,
Known severe hepatic impairment or AST and/or ALT > 3 times the upper limit of normal at screening,
Presence of any condition (medical, including clinically significant abnormal laboratory tests, psychological, social or geographical) actual or anticipated that the investigator feels would compromise the patient's safety or limit his/her successful participation to the study. In particular :
Ongoing major depressive illness,
Uncontrolled psychiatric illness,
History of alcohol or other substance abuse,
Hypersensitivity /intolerance to the active substance or to any of the excipients such as lactose,
Administration of any investigational treatment (drug or device) within 30 days prior to screening,
Previous participation in a Rimonabant study or previous administration of Rimonabant,
Administration of any of the following within 3 months prior to screening visit:
Ongoing antidepressive treatment(including bupropion)
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Primary purpose
Allocation
Interventional model
Masking
2,666 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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