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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
History of Changes
  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:

U.S. FDA Resources

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
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
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Body Weight
Signs and Symptoms
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013