Effects of Rimonabant on urinary albumin excretion rate on the components of the metabolic syndrome in patients with type 2 diabetes mellitus and microalbuminuria on background ramipril treatment. A prospective, randomized, double-blind, placebo-controlled pilot study. - EFFECTS

Phase 1

• Conditions: Abdominal obese patients with type 2 diabetes mellitus and microalbuminuria.; MedDRA version: 9.1Level: LLTClassification code 10059179Term: Abdominal obesity

• Registration Number: EUCTR2007-002077-31-IT
• Lead Sponsor: SANOFI-AVENTIS S.P.A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04-16
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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 <40kg/m2; 4 Waist Circumference >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

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 < 30 ml/min) or nephrotic syndrome or urinalysis (performed at screening by dipstick) showing 2+ or more protein, or ischemic renal disease; 11 Known severe hepatic impairment or AST and/or ALT > 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified