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

NCT ID: NCT00546325

Last Updated: 2010-12-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 358 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2009-02-28

Brief 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

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Rimonabant

Group Type: EXPERIMENTAL

Rimonabant

Intervention Type: DRUG

White opaque film-coated, for oral administration containing 20 mg of active rimonabant. Once daily before breakfast

2

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching placebo tablets. Once daily before breakfast

Interventions

Rimonabant

White opaque film-coated, for oral administration containing 20 mg of active rimonabant. Once daily before breakfast

Intervention Type: DRUG

Placebo

Matching placebo tablets. Once daily before breakfast

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

sanofi-aventis

Principal Investigators

David WHEATLEY

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis Administrative Office

North Ryde, , Australia

Countries

Australia

Other Identifiers

RIMON_L_01661

Identifier Type: -

Identifier Source: org_study_id