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

Study Overview
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Brief Summary
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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

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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Rimonabant
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Rimonabant | Drug: Rimonabant<br>* White opaque film-coated, for oral administration containing 20 mg of active rimonabant. Once daily before breakfast<br>|
| Placebo Comparator: 2<br>Placebo | Drug: Placebo<br>* Matching placebo tablets. Once daily before breakfast<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change in HbA1c between both placebo and rimonabant group. |  | From baseline to week 48 | 
| 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 | 
| Percentage of participants responding to treatment |  | From the beginning to the end of study | 
| Rate of asymptomatic, symptomatic, and severe hypoglycaemia |  | From the beginning to the end of the study | 
| Change in physical examinations, vital signs, laboratory parameters, adverse events |  | From the beginning to the end of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in insulin sensitivity, fasting plasma glucose, hypoglycaemia rate. |  | From the beginning to the end of the study | 
| Change in BMI, waist and hip circumference, waist/hip ratio, weight |  | From the beginning to the end of the study | 
| Changes in Quality of Life |  | From the beginning to the end of the study | 
| 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 | 
| 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 |