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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00688701 |
The purpose of this study is to evaluate the benefits and risks of AVE0010 in monotherapy in comparison to placebo, over a period of 12 weeks of treatment.
The primary objective is to assess the effects of AVE0010 on glycemic control in terms of HbA1c reduction at 12 weeks.
Secondary objectives are to assess the effects of AVE0010 on body weight, fasting plasma glucose, post-prandial plasma glucose changes, and to assess the safety and tolerability of AVE0010.
Condition | Intervention | Phase |
---|---|---|
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, Parallel-Group, Multicenter 12-Week Study Assessing the Efficacy and Safety of AVE0010 in Patients With Type 2 Diabetes Not Treated With Antidiabetic Agents |
Estimated Enrollment: | 360 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | July 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: AVE0010
12 weeks of treatment
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2: Placebo Comparator |
Drug: Placebo
12 weeks of treatment
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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 | |
Contact GV-Contact-us@sanofi-aventis.com | |
Belgium | |
Sanofi-Aventis Administrative Office | Recruiting |
Diegem, Belgium | |
Contact GV-Contact-us@sanofi-aventis.com | |
India | |
Sanofi-Aventis Administrative Office | Recruiting |
Mumbai, India | |
Contact GV-Contact-us@sanofi-aventis.com | |
Japan | |
Sanofi-Aventis Administrative Office | Recruiting |
Tokyo, Japan | |
Contact GV-Contact-us@sanofi-aventis.com | |
Korea, Republic of | |
Sanofi-Aventis Administrative Office | Recruiting |
Seoul, Korea, Republic of | |
Contact GV-Contact-us@sanofi-aventis.com | |
Mexico | |
Sanofi-Aventis Administrative Office | Recruiting |
Mexico, Mexico | |
Contact GV-Contact-us@sanofi-aventis.com | |
Poland | |
Sanofi-Aventis Administrative Office | Recruiting |
Warszawa, Poland | |
Contact GV-Contact-us@sanofi-aventis.com | |
Romania | |
Sanofi-Aventis Administrative Office | Recruiting |
Bucuresti, Romania | |
Contact GV-Contact-us@sanofi-aventis.com | |
Russian Federation | |
Sanofi-Aventis Administrative Office | Recruiting |
Moscow, Russian Federation | |
Contact GV-Contact-us@sanofi-aventis.com | |
Tunisia | |
Sanofi-Aventis Administrative Office | Recruiting |
Megrine, Tunisia | |
Contact GV-Contact-us@sanofi-aventis.com |
Study Director: | ICD CSD | Sanofi-Aventis |
Responsible Party: | sanofi-aventis ( International Clinical Development Study Director ) |
Study ID Numbers: | EFC6018, EudraCT 2007-005887-29 |
Study First Received: | May 7, 2008 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00688701 |
Health Authority: | United States: Food and Drug Administration |
hyperglycemia, GLP-1 |
Metabolic Diseases Hyperglycemia Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Glucagon-Like Peptide 1 |