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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00713830 |
The purpose of this study is to evaluate the benefits and risks of AVE0010 in association with sulfonylurea without or with metformin in comparison to placebo, 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.
Secondary objectives are to assess the effects of AVE0010 on body weight, fasting plasma glucose, relevant metabolic parameters in type 2 diabetes, and to assess safety and tolerability of AVE0010.
Condition | Intervention | Phase |
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Diabetes Mellitus, Type 2 |
Drug: AVE0010 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, 2-Arm Parallel-Group, Multicenter 24-Week Study Followed by an Extension Assessing the Efficacy and Safety of AVE0010 on Top of a Sulfonylurea in Patients With Type 2 Diabetes Not Adequately Controlled With Sulfonylurea |
Estimated Enrollment: | 855 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | March 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: Placebo Comparator |
Drug: Placebo
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 |
United States, New Jersey | |
Sanofi-Aventis Administrative Office | Recruiting |
Bridgewater, New Jersey, United States, 08807 | |
Bulgaria | |
Sanofi-Aventis Administrative Office | Recruiting |
Sofia, Bulgaria | |
Czech Republic | |
Sanofi-Aventis Administrative Office | Recruiting |
Praha, Czech Republic | |
Egypt | |
Sanofi-Aventis Administrative Office | Recruiting |
Cairo, Egypt | |
Germany | |
Sanofi-Aventis Administrative Office | Recruiting |
Berlin, Germany | |
India | |
Sanofi-Aventis Administrative Office | Recruiting |
Mumbai, India | |
Israel | |
Sanofi-Aventis Administrative Office | Recruiting |
Natanya, Israel | |
Japan | |
Sanofi-Aventis Administrative Office | Recruiting |
Tokyo, Japan | |
Korea, Republic of | |
Sanofi-Aventis Administrative Office | Recruiting |
Seoul, Korea, Republic of | |
Netherlands | |
Sanofi-Aventis Administrative Office | Recruiting |
Gouda, Netherlands | |
Romania | |
Sanofi-Aventis Administrative Office | Recruiting |
Bucuresti, Romania | |
Russian Federation | |
Sanofi-Aventis Administrative Office | Recruiting |
Moscow, Russian Federation | |
Taiwan | |
Sanofi-Aventis Administrative Office | Recruiting |
Taipei, Taiwan | |
Thailand | |
Sanofi-Aventis Administrative Office | Recruiting |
Bangkok, Thailand | |
Tunisia | |
Sanofi-Aventis Administrative Office | Recruiting |
Megrine, Tunisia | |
Turkey | |
Sanofi-Aventis Administrative Office | Recruiting |
Istanbul, Turkey |
Study Director: | ICD CSD | Sanofi-Aventis |
Responsible Party: | Sanofi-aventis ( ICD Study Director ) |
Study ID Numbers: | EFC6015, EudraCT 2007-005881-11 |
Study First Received: | July 10, 2008 |
Last Updated: | May 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00713830 History of Changes |
Health Authority: | United States: Food and Drug Administration |
hyperglycemia, GLP-1 |
Metabolic Diseases Hyperglycemia Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Glucagon-Like Peptide 1 |
Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders |