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

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

Primary outcomes

• 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 outcomes

• 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]

Sex: All, ages: 18 Years to 75 Years

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.

• David WHEATLEY, Study director, Sanofi