REASSURE: The Effect of Rimonabant on HbA1c in Overweight or Obese Patients With Type 2 Diabetes Not Adequately Controlled on 2 Oral Antidiabetic Agents
- Registration Number
- NCT00546325
- Lead Sponsor
- Sanofi
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 358
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Rimonabant Rimonabant 2 Placebo Placebo
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (1)
Sanofi-Aventis Administrative Office
🇦🇺North Ryde, Australia