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 Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 Rimonabant |
Drug: Rimonabant
White opaque film-coated, for oral administration containing 20 mg of active rimonabant. Once daily before breakfast
|
| Placebo Comparator: 2 Placebo |
Drug: Placebo
Matching placebo tablets. Once daily before breakfast
|
Outcome Measures
Primary Outcome Measures
- 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
- 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]
Eligibility Criteria
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
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Severe renal impairment (creatinine clearance less than 30ml/min)
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Severe hepatic impairment known by investigator or Aspartate Aminotransferase and/or Alanine Aminotransferase > 3 times Upper Limit Normal
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Patient treated for epilepsy
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Pregnant or breast-feeding women
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Women of childbearing potential not protected by effective contraception
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Hypersentivity/intolerance to rimonabant or any of the excipents
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Presence of any condition, current or anticipated that in the investigator's opinion would compromise the patient's safety
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Use of insulin for longer than 1 week within 4 weeks prior to screening
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Chronic use of systemic corticosteriods
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Use of glitazone therapy, glucagon-like peptide or dipeptidyl peptidase IV
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History of drug or alcohol abuse wihtin the last three years
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Heart failure class III-IV (New York Heart Association classification)
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Severe hypertension
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Adminstration of the following medications: phentermine, amphetamines, orlistat, sibutramine, herbal remedies
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Use of non-lipid agents known to affect lipid metabolism: retinoids, antiretrovirals, hormone replacement therapy containing estrogens, cyclosporin, thiazolidinediones (glitazones), fish oils, plant sterols
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Use of ketoconazole, itraconazole, ritonavir, clarithromycin, rifampicin, phenytoin, phenobarbitone, carbamazepine or St John's Wort
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Participation in a clinical study within the 4 weeks prior to randomisation
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Patients involved in an existing weight loss program
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Presence of chronic hepatitis
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Use, or misuse, of substances of abuse
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Marijuana or hashish users
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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
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History or presence of bulimia or laxative abuse
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Non-English speaking
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sanofi-Aventis Administrative Office | North Ryde | Australia |
Sponsors and Collaborators
- Sanofi
Investigators
- Study Director: David WHEATLEY, Sanofi
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RIMON_L_01661