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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00707031 |
The purpose of this study is to compare the benefits and risks of AVE0010 versus exenatide in association with metformin, over a period of 24 weeks of treatment, followed by an extension.
The primary objective is to assess the effects of AVE0010 on glycemic control in terms of HbA1c reduction at 24 weeks.
The secondary objectives are to assess the effects of AVE0010 on body weight, fasting plasma glucose, relevant metabolic parameters in type 2 diabetes, and to evaluate safety, tolerability and quality of life.
Condition | Intervention | Phase |
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Diabetes Mellitus, Type 2 |
Drug: AVE0010 Drug: Exenatide |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomized, Open-Label, Active-Controlled, 2-Arm Parallel-Group, Multicenter 24-Week Study Followed by an Extension Assessing the Efficacy and Safety of AVE0010 Versus Exenatide on Top of Metformin in Patients With Type 2 Diabetes Not Adequately Controlled With Metformin |
Estimated Enrollment: | 600 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | April 2010 |
Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: AVE0010
At least 24 weeks of treatment extension period of variable duration
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2: Active Comparator |
Drug: Exenatide
At least 24 weeks of treatment extension period of variable duration
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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.
Contact: Public Registry ICD | GV-Contact-us@sanofi-aventis.com |
Study Director: | ICD | Sanofi-Aventis |
Responsible Party: | Sanofi-aventis ( ICD Study Director ) |
Study ID Numbers: | EFC6019, EudraCT 2007-005883-28 |
Study First Received: | June 26, 2008 |
Last Updated: | November 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00707031 |
Health Authority: | United States: Food and Drug Administration |
hyperglycemia, GLP-1, metformin |
Metabolic Diseases Hyperglycemia Exenatide Metformin Diabetes Mellitus, Type 2 Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Glucagon-Like Peptide 1 |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |