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| Sponsor: | Sanofi-Aventis |
|---|---|
| Information provided by: | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT00449605 |
Purpose
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
|
Eligibility| 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.
Contacts and Locations| 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 |
More Information
| 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 |
|
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 |