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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00478972 |
The primary objective of this study is to assess the efficacy of SR141716 (rimonabant) compared to placebo on change in HbA1c and on relative change in body weight over 36 weeks in obese type 2 diabetic patients inadequately controlled with diet and exercise alone.
The secondary objectives are:
Condition | Intervention | Phase |
---|---|---|
Obesity Diabetes Mellitus Type 2 |
Drug: rimonabant (SR141716) Drug: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed Single-Dose Regimen, Multicenter Study to Assess the Efficacy and Safety of SR141716 in Obese Type 2 Diabetic Patients Inadequately Controlled With Diet and Exercise Alone |
Estimated Enrollment: | 306 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | February 2009 |
Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: rimonabant (SR141716)
oral administration
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2: Placebo Comparator |
Drug: placebo
oral administration
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Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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.
Responsible Party: | sanofi-aventis ( ICD Study Director ) |
Study ID Numbers: | EFC6648 |
Study First Received: | May 24, 2007 |
Last Updated: | November 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00478972 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare; United States: Food and Drug Administration |
obese diabetes cannabinoid-1 receptor |
Obesity Metabolic Diseases Diabetes Mellitus Endocrine System Diseases Overweight Body Weight Signs and Symptoms |
Diabetes Mellitus, Type 2 Nutrition Disorders Overnutrition Endocrinopathy Glucose Metabolism Disorders Metabolic disorder |