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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Rimonabant |
|
| 2 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rimonabant | Drug | White opaque film-coated, for oral administration containing 20 mg of active rimonabant. Once daily before breakfast |
|
| 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 |
| 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 |
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List of Inclusion and Exclusion criteria:
Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| David WHEATLEY | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Administrative Office | North Ryde | Australia |
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| Placebo | Drug | Matching placebo tablets. Once daily before breakfast |
|
| 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 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000077285 | Rimonabant |
| ID | Term |
|---|---|
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010880 | Piperidines |
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