REASSURE: The Effect of Rimonabant on HbA1c in Overweight or Obese Patients With Type 2 Diabetes Not Adequately Controlled on 2 Oral Antidiabetic Agents

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Primary:

To assess the effects of rimonabant on HbA1c in patients with Type 2 diabetes who are overweight or obese (Body Mass Index (BMI) > 27 kg/m² and BMI < 40 kg/m²), have uncontrolled HbA1c (7.0% - 9.0% inclusive) and are currently on maximal tolerated doses of two Oral Anti Diabetic medications - Metformin (Met) and Sulfonylurea (SU).

Secondary:

To assess the effects of rimonabant on Anthropometric measures, Glucose measures, Lipid measures, Other measures and changes in quality of life

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Hypoglycemic Agents; Rimonabant

Criteria

List of Inclusion and Exclusion criteria:

Inclusion Criteria:

• History of Type 2 diabetes

• HbA1c between 7% to 9% (inclusive)

• BMI ≥ 27kg/m² and BMI ≤ 40kg/m²

• Currently taking Metformin and Sulfonylurea.

Exclusion Criteria:

• Uncontrolled serious psychiatric illness such as major depression

• Current use of antidepressants

• Severe renal impairment (creatinine clearance less than 30ml/min)

• Severe hepatic impairment known by investigator or Aspartate Aminotransferase and/or Alanine Aminotransferase > 3 times Upper Limit Normal

• Patient treated for epilepsy

• Pregnant or breast-feeding women

• Women of childbearing potential not protected by effective contraception

• Hypersentivity/intolerance to rimonabant or any of the excipents

• Presence of any condition, current or anticipated that in the investigator's opinion would compromise the patient's safety

• Use of insulin for longer than 1 week within 4 weeks prior to screening

• Chronic use of systemic corticosteriods

• Use of glitazone therapy, glucagon-like peptide or dipeptidyl peptidase IV

• History of drug or alcohol abuse wihtin the last three years

• Heart failure class III-IV (New York Heart Association classification)

• Severe hypertension

• Adminstration of the following medications: phentermine, amphetamines, orlistat, sibutramine, herbal remedies

• Use of non-lipid agents known to affect lipid metabolism: retinoids, antiretrovirals, hormone replacement therapy containing estrogens, cyclosporin, thiazolidinediones (glitazones), fish oils, plant sterols

• Use of ketoconazole, itraconazole, ritonavir, clarithromycin, rifampicin, phenytoin, phenobarbitone, carbamazepine or St John's Wort

• Participation in a clinical study within the 4 weeks prior to randomisation

• Patients involved in an existing weight loss program

• Presence of chronic hepatitis

• Use, or misuse, of substances of abuse

• Marijuana or hashish users

• History of gastrointestinal surgery for weight loss purposes or who are scheduled for such surgery within the duration of their expected participation in this study

• History or presence of bulimia or laxative abuse

• Non-English speaking

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.