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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00478595 |
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 52 weeks in obese type 2 diabetic patients on monotherapy inadequately controlled with oral anti-diabetic drug (sulfonylurea or α-glucosidase inhibitor).
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, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Assess the Efficacy and Safety of SR141716 in Obese Type 2 Diabetic Patients on Monotherapy Inadequately Controlled With Oral Anti-Diabetic Drug |
Estimated Enrollment: | 450 |
Study Start Date: | May 2007 |
Study Completion Date: | February 2009 |
Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: rimonabant (SR141716)
one tablet/day
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2: Placebo Comparator |
Drug: Placebo
one tablet/day
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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: | EFC6647 |
Study First Received: | May 24, 2007 |
Last Updated: | March 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00478595 History of Changes |
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 |
Hypoglycemic Agents Diabetes Mellitus, Type 2 Nutrition Disorders Overnutrition Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder |
Obesity Metabolic Diseases Physiological Effects of Drugs Diabetes Mellitus Endocrine System Diseases Overweight Pharmacologic Actions |
Body Weight Signs and Symptoms Hypoglycemic Agents Diabetes Mellitus, Type 2 Nutrition Disorders Overnutrition Glucose Metabolism Disorders |