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

Overview

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

Full Title of Study: “REASURE: The Effect of Rimonabant on HbA1c in Overweight or Obese Patients With Type 2 Diabetes Not Adequately Controlled on 2 Oral Antidiabetic Agents”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: February 2009

Interventions

  • Drug: Rimonabant
    • White opaque film-coated, for oral administration containing 20 mg of active rimonabant. Once daily before breakfast
  • Drug: Placebo
    • Matching placebo tablets. Once daily before breakfast

Arms, Groups and Cohorts

  • Experimental: 1
    • Rimonabant
  • Placebo Comparator: 2
    • Placebo

Clinical Trial Outcome Measures

Primary Measures

  • Absolute change in HbA1c between both placebo and rimonabant group.
    • Time Frame: From baseline to week 48
  • Percentage of participants reaching the treat-to-target objective of HbA1c ≤ 6.5% and ≤ 7.0%
    • Time Frame: From the beginning to the end of the study
  • Percentage of participants responding to treatment
    • Time Frame: From the beginning to the end of study
  • Rate of asymptomatic, symptomatic, and severe hypoglycaemia
    • Time Frame: From the beginning to the end of the study
  • Change in physical examinations, vital signs, laboratory parameters, adverse events
    • Time Frame: From the beginning to the end of the study

Secondary Measures

  • Change in insulin sensitivity, fasting plasma glucose, hypoglycaemia rate.
    • Time Frame: From the beginning to the end of the study
  • Change in BMI, waist and hip circumference, waist/hip ratio, weight
    • Time Frame: From the beginning to the end of the study
  • Changes in Quality of Life
    • Time Frame: From the beginning to the end of the study
  • Change in lipid measures: HDL (High Density Lipoprotein), LDL (Low-Density Lipoprotein), TG (Triglycerides), TC (Total Cholesterol), ApoB (Apolipoprotein B)
    • Time Frame: From administration of drug till end of study
  • Change in adiponectin, fasting insulin, Blood Pressure, concomitant medications, health resource use, CRP (C Reactive Protein), ALT (Alanine Aminotransferase), albumin/creatinine ratio
    • Time Frame: From administration of drug to end of study

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sanofi
  • Provider of Information About this Clinical Study
    • Trial Transparency Team, sanofi-aventis
  • Overall Official(s)
    • David WHEATLEY, Study Director, Sanofi

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