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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00690456 |
The primary objective of the study is to determine the effect of rimonabant 20 mg daily when added to ongoing metformin therapy on glycemic control (HbA1c) over a 36 week period in patients with type 2 diabetes.
Secondary objectives include evaluation of other markers of glycemic control, lipid profile, body weight, and abdominal obesity. Also, the trial will study the safety of rimonabant when added to metformin over a period of 47 weeks.
Condition | Intervention | Phase |
---|---|---|
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 Study Evaluating the Glycemic Effect of Rimonabant Added to Metformin in Patients With Type 2 Diabetes Insufficiently Controlled With Metformin Monotherapy |
Estimated Enrollment: | 360 |
Study Start Date: | May 2008 |
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)
added to metformin
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2: Placebo Comparator |
Drug: placebo
added to metformin
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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 | |
Indonesia | |
Sanofi-Aventis Administrative Office | |
Jakarta, Indonesia | |
Lithuania | |
Sanofi-Aventis Administrative Office | |
Vilnius, Lithuania | |
Malaysia | |
Sanofi-Aventis Administrative Office | |
Kuala Lumpur, Malaysia | |
Mexico | |
Sanofi-Aventis Administrative Office | |
Mexico, Mexico | |
Philippines | |
Sanofi-Aventis Administrative Office | |
Makati City, Philippines | |
Poland | |
Sanofi-Aventis Administrative Office | |
Warszawa, Poland | |
Romania | |
Sanofi-Aventis Administrative Office | |
Bucuresti, Romania | |
Russian Federation | |
Sanofi-Aventis Administrative Office | |
Moscow, Russian Federation | |
Slovakia | |
Sanofi-Aventis Administrative Office | |
Bratislava, Slovakia | |
Taiwan | |
Sanofi-Aventis Administrative Office | |
Taipei, Taiwan | |
Thailand | |
Sanofi-Aventis Administrative Office | |
Bangkok, Thailand | |
Ukraine | |
Sanofi-Aventis Administrative Office | |
Kiev, Ukraine |
Study Director: | ICD CSD | Sanofi-Aventis |
Responsible Party: | Sanofi-aventis ( ICD Study Director ) |
Study ID Numbers: | EFC10518, EudraCT 2007-004833-40 |
Study First Received: | May 7, 2008 |
Last Updated: | November 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00690456 |
Health Authority: | United States: Food and Drug Administration |
Randomized Controlled Trial Metformin |
Metabolic Diseases Metformin Diabetes Mellitus, Type 2 Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |