Diabetes Mellitus, Type 2, Dyslipidemia, Microalbuminuria, Obesity
Conditions
Brief 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
Interventions
DRUGRimonabant
20 mg once per day + slightly reduced calorie diet
DRUGPlacebo
placebo once per day + slightly reduced calorie diet
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relative change in the microalbuminuria level. | between baseline visit and Month 12 |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients whose albuminuria levels decrease, stabilise, are progressing towards macroalbuminuria, are unaltered. | 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 | between baseline visit and Month 12 |
| Evaluation of the Quality of Life (questionnaire IWQOL). | at baseline visit and at 3, 6 and 12 months visit |
| Safety (including neuropsychiatric events) and Laboratory assessments. | at each visit and at baseline, 3, 6 and 12 month visits |
Countries
Spain
Outcome results
None listed