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

Sanofi

Status and phase

Completed

Phase 3

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: Rimonabant

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00546325

RIMON_L_01661

Details and patient eligibility

About

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

Enrollment

358 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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