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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00449605 |
The primary objective is to demonstrate, after 52 weeks of treatment, the non-inferiority of rimonabant 20 mg od versus glimepiride od in reducing HbA1c in overweight/obese patients with type 2 diabetes not adequately controlled with metformin at a stable dose (≥ 1500 mg/day) for at least 3 months.
The main secondary objectives are to assess the effect of rimonabant in comparison with glimepiride on body weight and HDL-Cholesterol and the long-term safety and tolerability of rimonabant in comparison with glimepiride.
Condition | Intervention | Phase |
---|---|---|
Diabetes Mellitus, Type 2 |
Drug: rimonabant (SR141716) Drug: glimepiride |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomized, Double-Blind, Parallel-Group, Multicenter, Multinational Study to Assess Glycemic Control With Rimonabant in Comparison With Glimepiride Over 1 Year in Overweight/Obese Type2 Diabetic Patients Not Adequately Controlled With Metformin |
Enrollment: | 508 |
Study Start Date: | March 2007 |
Study Completion Date: | March 2009 |
Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: rimonabant (SR141716)
on top of metformin
|
2: Active Comparator |
Drug: glimepiride
on top of metformin
|
Ages Eligible for Study: | 18 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.
United States, New Jersey | |
Sanofi-aventis Administrative Office | |
Bridgewater, New Jersey, United States, 08807 | |
Chile | |
Sanofi-aventis Administrative Office | |
Santiago, Chile | |
Sanofi-aventis adminsitrative office | |
Santiago, Chile | |
Denmark | |
Sanofi-aventis Administrative Office | |
Horsholm, Denmark | |
Finland | |
Sanofi-aventis Administrative Office | |
Helsinki, Finland | |
Hungary | |
Sanofi-aventis Administrative Office | |
Budapest, Hungary | |
India | |
Sanofi-aventis Administrative Office | |
Mumbai, India | |
Italy | |
Sanofi-aventis Administrative Office | |
Milan, Italy | |
Korea, Republic of | |
Sanofi-aventis Administrative Office | |
Seoul, Korea, Republic of | |
Mexico | |
Sanofi-aventis Administrative Office | |
Mexico, Mexico | |
Puerto Rico | |
Sanofi-aventis Administrative Office | |
Puerto Rico, Puerto Rico | |
Romania | |
Sanofi-aventis Administrative Office | |
Bucuresti, Romania | |
Russian Federation | |
Sanofi-aventis Administrative Office | |
Moscow, Russian Federation | |
Spain | |
Sanofi-aventis Administrative Office | |
Barcelona, Spain | |
Sweden | |
Sanofi-aventis Administrative Office | |
Bromma, Sweden |
Study Director: | ICD | Sanofi-Aventis |
Responsible Party: | sanofi-aventis ( ICD Study Director ) |
Study ID Numbers: | EFC10007, EUDRACT: 2006-005385-39 |
Study First Received: | March 19, 2007 |
Last Updated: | June 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00449605 History of Changes |
Health Authority: | United States: Food and Drug Administration; Mexico: Ministry of Health |
Diabetes Metformin |
Obesity Metabolic Diseases Immunologic Factors Metformin Diabetes Mellitus Endocrine System Diseases Overweight Cardiovascular Agents |
Immunosuppressive Agents Glimepiride Hypoglycemic Agents Diabetes Mellitus, Type 2 Anti-Arrhythmia Agents Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder |
Metabolic Diseases Immunologic Factors Metformin Physiological Effects of Drugs Diabetes Mellitus Endocrine System Diseases Cardiovascular Agents Immunosuppressive Agents |
Pharmacologic Actions Glimepiride Hypoglycemic Agents Therapeutic Uses Diabetes Mellitus, Type 2 Anti-Arrhythmia Agents Glucose Metabolism Disorders |