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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
174
20 mg once per day + slightly reduced calorie diet
placebo once per day + slightly reduced calorie diet
Sanofi-Aventis Administrative Office
Barcelona, Spain
Relative change in the microalbuminuria level.
Time frame: between baseline visit and Month 12
Percentage of patients whose albuminuria levels decrease, stabilise, are progressing towards macroalbuminuria, are unaltered.
Time frame: between baseline visit and Month 12
Relative change and absolute change of Weight, Waist circumference, Body mass index (weight and height), Specific lipid parameters, Glycaemia control parameters, Proinflammatory markers, Adipocytokines, Glomerular filtration rate, Blood pressure
Time frame: between baseline visit and Month 12
Evaluation of the Quality of Life (questionnaire IWQOL).
Time frame: at baseline visit and at 3, 6 and 12 months visit
Safety (including neuropsychiatric events) and Laboratory assessments.
Time frame: at each visit and at baseline, 3, 6 and 12 month visits
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