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

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

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

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Rimonabant; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 358
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • North Ryde, Australia
    • Sanofi-Aventis Administrative Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 2; Placebo	Drug: Placebo; Matching placebo tablets. Once daily before breakfast
Experimental: 1; Rimonabant	Drug: Rimonabant; White opaque film-coated, for oral administration containing 20 mg of active rimonabant. Once daily before breakfast

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in insulin sensitivity, fasting plasma glucose, hypoglycaemia rate.	From the beginning to the end of the study
Change in BMI, waist and hip circumference, waist/hip ratio, weight	From the beginning to the end of the study
Changes in Quality of Life	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)	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	From administration of drug to end of study

Collaborators and Investigators

• Sponsor: Sanofi
• Investigators: Study Director: David WHEATLEY, Sanofi

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): February 1, 2009
• Study Completion (Actual): February 1, 2009

Study Registration Dates

• First Submitted: October 17, 2007
• First Submitted That Met QC Criteria: October 17, 2007
• First Posted (Estimate): October 18, 2007

Study Record Updates

• Last Update Posted (Estimate): December 10, 2010
• Last Update Submitted That Met QC Criteria: December 9, 2010
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Body Weight; Diabetes Mellitus; Diabetes Mellitus, Type 2; Overweight; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Obesity Agents; Cannabinoid Receptor Modulators; Cannabinoid Receptor Antagonists; Rimonabant
• Other Study ID Numbers: RIMON_L_01661