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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00546325
First received: October 17, 2007
Last updated: December 9, 2010
Last verified: December 2010
  Purpose

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


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Rimonabant
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: REASURE: The Effect of Rimonabant on HbA1c in Overweight or Obese Patients With Type 2 Diabetes Not Adequately Controlled on 2 Oral Antidiabetic Agents

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Absolute change in HbA1c between both placebo and rimonabant group. [ Time Frame: From baseline to week 48 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Percentage of participants responding to treatment [ Time Frame: From the beginning to the end of study ] [ Designated as safety issue: No ]
  • Rate of asymptomatic, symptomatic, and severe hypoglycaemia [ Time Frame: From the beginning to the end of the study ] [ Designated as safety issue: No ]
  • Change in physical examinations, vital signs, laboratory parameters, adverse events [ Time Frame: From the beginning to the end of the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in insulin sensitivity, fasting plasma glucose, hypoglycaemia rate. [ Time Frame: From the beginning to the end of the study ] [ Designated as safety issue: No ]
  • Change in BMI, waist and hip circumference, waist/hip ratio, weight [ Time Frame: From the beginning to the end of the study ] [ Designated as safety issue: No ]
  • Changes in Quality of Life [ Time Frame: From the beginning to the end of the study ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 358
Study Start Date: October 2007
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Rimonabant
Drug: Rimonabant
White opaque film-coated, for oral administration containing 20 mg of active rimonabant. Once daily before breakfast
Placebo Comparator: 2
Placebo
Drug: Placebo
Matching placebo tablets. Once daily before breakfast

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00546325

Locations
Australia
Sanofi-Aventis Administrative Office
North Ryde, Australia
Sponsors and Collaborators
Sanofi
Investigators
Study Director: David WHEATLEY Sanofi
  More Information

No publications provided

Responsible Party: Trial Transparency Team, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00546325     History of Changes
Other Study ID Numbers: RIMON_L_01661
Study First Received: October 17, 2007
Last Updated: December 9, 2010
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Overweight
Body Weight
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Signs and Symptoms
Hypoglycemic Agents
Rimonabant
Cannabinoid Receptor Antagonists
Cannabinoid Receptor Modulators
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 29, 2014