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

Diabetes Mellitus, Type 2 Clinical Trial

— REASSURE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00546325
• Other study ID #: RIMON_L_01661
• Status: Completed
• Phase: Phase 3
• First received: October 17, 2007
• Last updated: December 9, 2010
• Start date: October 2007
• Est. completion date: February 2009

Study information

• Verified date: December 2010
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 358
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• Rimonabant
White opaque film-coated, for oral administration containing 20 mg of active rimonabant. Once daily before breakfast
• Placebo
Matching placebo tablets. Once daily before breakfast

Locations

Country	Name	City	State
Australia	Sanofi-Aventis Administrative Office	North Ryde

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute change in HbA1c between both placebo and rimonabant group.		From baseline to week 48	No
Primary	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	No
Primary	Percentage of participants responding to treatment		From the beginning to the end of study	No
Primary	Rate of asymptomatic, symptomatic, and severe hypoglycaemia		From the beginning to the end of the study	No
Primary	Change in physical examinations, vital signs, laboratory parameters, adverse events		From the beginning to the end of the study	Yes
Secondary	Change in insulin sensitivity, fasting plasma glucose, hypoglycaemia rate.		From the beginning to the end of the study	No
Secondary	Change in BMI, waist and hip circumference, waist/hip ratio, weight		From the beginning to the end of the study	No
Secondary	Changes in Quality of Life		From the beginning to the end of the study	No
Secondary	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	No
Secondary	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	No