evaluation of the rimonabant impact on the regression of asymptomatic damage caused by cardiovascular risk factors

Conditions: Obesity; Microalbuminuria; Diabetes Mellitus, Type 2; Dyslipidemia

Summary: primary objective: * to assess the effect on microalbuminuria levels of treatment with rimonabant 20 mg versus a placebo during a 12 month period. secondary objectives: * percentage of patients in both arms of the study whose levels of microalbuminuria decrease, stabilise, increase towards macroalbuminuria or are unchanged after 12 months of treatment with rimonabant or placebo. * to assess the effect of treatment with rimonabant 20 mg versus placebo over a 12 month period on: * weight and waist circumference. * glycaemia profile: fasting glycaemia, fasting insulinaemia and hba1c. * lipid and lipoprotein profile: triglycerides, total cholesterol, hdl-c, ldl-c, apolipoproteins a1 and b. * inflammatory markers * adipocytokines. * blood pressure. * glomerular filtration rate. * to assess the quality of life by means of questionnaire filled in. * safety parameters


Eligibility criteria:
inclusion criteria: * body mass index \> 27 kg/m2 and \< 40 kg/m2. * waist circumference \> 102 cm in men and \> 88 cm in women. * microalbuminuria \>= 20 mg/g creatinine and \< 300 mg/g creatinine in at least two of three morning urine samples taken on 3 separate days prior to the baseline visit. * type 2 diabetes and/or dyslipidaemia. exclusion criteria: * breastfeeding or pregnant women or who expect to become pregnant. * non-use of approved methods of contraception in women of child-bearing potential. * history of very low calorie diet in the 3 months prior to the screening visit (\<1200 kcal/day). * change in weight \> 5 kg in the 3 months prior to the screening visit. * history of surgery for weight loss (such as vertical banded gastroplasty, gastric by-pass, etc.) * history of bulimia or anorexia nervosa according to dsm-iv definition. * any clinically significant endocrine disorder, in the opinion of the investigator, especially known alterations in the blood concentration of tsh and free t4. * type 1 diabetes * triglyceridaemia \> 400 mg/dl (4.52 mmol/l) * severe renal dysfunction * chronic hepatitis or clinically known significant liver disease or alt and/or ast \> 3x the upper limit of the normal range at the screening visit. * hypertension at the screening visit. * presence of any condition (medical, including clinically significant abnormal laboratory tests, physiological, 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. * history of abuse of alcohol or other substances (except smoking). * hypersensitivity or intolerance to the active ingredient or any of the excipients, such as lactose. concomitant medication prior to the screening visit * administration of any treatment undergoing clinical investigation (drug or medical device) in the 30 days prior to the screening visit. * previous treatment with rimonabant. * administration of any of the following products in the 3 months prior to the screening visit * anti-obesity drugs (such as, sibutramine or orlistat). * other weight loss drugs (phentermine,amphetamines). * weight loss herbal preparations. * nicotinic acid, fibrates, bile acid sequestrants or omega 3 drugs (e.g. omacor). * prolonged use (more than a week) of systemic corticosteroids or neuroleptics * antidepressants (including bupropion) * insulin, thiazolidinediones, α-glucosidase inhibitors, meglitinides or any group of antidiabetic drugs (except combination of biguanides and sulfonylureas) * in type 2 diabetes patients, start of or change in treatment with sulfonylureas and/or metformin, in the 4 weeks prior to the screening visit. * start of or change in treatment with antihypertensive drugs in the 12 weeks prior to the screening visit. * start of or change in treatment with statins and/or ezetimibe in the 8 weeks prior to the screening visit. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.