Abdominal obese patients with type 2 diabetes mellitus and microalbuminuria. MedDRA version: 9.1 Level: LLT Classification code 10059179 Term: Abdominal obesity
Conditions
Interventions
Product Name: RIMONABANT
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: RIMONABANT
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical
Sponsors
SANOFI-AVENTIS S.P.A
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Male or female 40-75 years of age; 2 T2DM (antidiabetic therapy and/or at least 2 values of fasting plasma glucose (FPG) >126 mg/dl) (ADA criteria); 3 BMI >27kg/m2 and 88 cm in women, >102 cm in men; 5 UAE 20-200 µg/min; 6 Treatment with ACEi or ARB as antihypertensive and/or antiproteinuric therapy (at least for 6 months and at least till 1 month prior to screening visit); 7 Informed consent must be obtained in writing for all subjects at enrollment into the study; 8 Willingness and ability to comply with the study protocol; Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1 Inability to give a written informed consent; 2 Pregnant, breast feeding, pregnancy or breast feeding planning, and ineffective contraception in women with childbearing potential; 3 History of very low-calorie diet within 3 months prior to screening visit (lower than 1200 Kcal/day); 4 Weight change > 5 kg within 3 months prior to screening visit; 5 History of surgical procedures for weight loss (e.g., stomach stapling, bypass); 6 History of bulimia or anorexia nervosa as per DSM-IV criteria; 7 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); 8 Triglyceride level >400 mg/dL (4.52 mmol); 9 Systolic blood pressure > 160 mm Hg or diastolic blood pressure >100 mmHg at screening visit; 10 Known severe renal dysfunction (creatinine clearance 3 times the upper limit of normal at screening; 12 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 : a. Cardiac abnormalities: cardiac failure status NYHA III or IV, relevant acute abnormal finding seen on ECG at screening or within 6 months before screening; b. Any current malignancy or any cancer within the past five years (except adequately treated basal cell skin cancer or cervix carcinoma in situ); c. Significant haematology abnormalities (haemoglobin < 100 g/L and/or neutrophils <1.5 G/L and/or platelets <100 G/L); d. Acute psychiatric disorders, mental condition or clinical relevant history of epilepsy which could interfere with the patient?s compliance or safe participation in the study; 13 Ongoing major depressive illness; 14 Uncontrolled psychiatric illness; 15 Story of alcohol or other substance abuse; 16 Hypersensitivity/intolerance to the active substance or to any of the excipients such as lactose; 17 Concomitant medications prior and during the study: a. Administration of any investigational treatment (drug or device) within 30 days prior to screening; b. Previous participation in a Rimonabant study; c. Administration of any of the following within 3 months prior to screening visit: - Anti obesity drugs (eg, sibutramine, orlistat); - Other drugs for weight reduction (phentermine, amphetamines); - Herbal preparations for weight reduction; - Nicotinic acid, fibrates or bile acid sequestrants ; - Prolonged use (more than one week) of systemic corticosteroids, neuroleptics; d. Ongoing antidepressive treatment (including bupropion); e. Change of hypolipidemic therapy with statins within 8 weeks prior to screening visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effects of 9-month Rimonabant treatment as compared to placebo on overnight urinary albumin excretion (UAE) rate (considered as a continuous variable) in overweight (BMI >27), abdominal obese patients with T2DM and microalbuminuria (UAE 20-200 µg/min) on background ACE inhibitor (ramipril) therapy.;Secondary Objective: To determine the effect of 9 months Rimonabant treatment versus placebo on changes in: Body weight, waist circumference (WC), BMI ; Glucose metabolic parameters (fasting glucose, fasting insulinemia, HbA1C, HOMA- IR); Lipid and lipoprotein profile (Total Cholesterol, HDL-C, LDL-C, triglyceride, apoprotein A1 and B); Hormone and adipokines concentrations (glucagone, leptin, adiponectin); GFR [as assessed by iohexol plasma clearance], albumin fractional clearance; Through (before study drug administration) and 24-hour blood pressure ; Need for antidiabetic, antihypertensive and lipid lowering agents ; Overall cardiovascular disease risk score ; Quality of life: IWQOL questionnaire . To determine the effect of 9 months Rimonabant treatment versus placebo on progression to macroalbuminuria (UAE >200 µg/min) and on regression to normoalbuminuria (UAE <20 µg/min). To assess the safety of 9 months Rimonabant treatment versus placebo in these patients.;Primary end point(s): Mean change from baseline to month 9 in UAE. | — |
Countries
Italy
Outcome results
None listed