Tracking Information
Start Date ICMJE | August 2009 |
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Estimated Primary Completion Date | April 2011 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: September 14, 2009) | Percentage of patients with HbA1c values <7% AND a weight loss of at least 5% of baseline body weight [ Time Frame: 24 weeks ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00976937 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: September 14, 2009) |
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Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | 24-week Study Comparing Lixisenatide (AVE0010) to Sitagliptin as add-on to Metformin in Obese Type 2 Diabetic Patients Younger Than 50 |
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Official Title ICMJE | A Randomized, Double-blind, Double-dummy, 2-arm Parallel-group, Multicenter 24-week Study Comparing the Efficacy and Safety of AVE0010 to Sitagliptin as add-on to Metformin in Obese Type 2 Diabetic Patients Younger Than 50 and Not Adequately Controlled With Metformin |
Brief Summary | The primary objective of this study is to assess the efficacy of lixisenatide (AVE0010) on a composite endpoint of glycemic control (HbA1c) and body weight in comparison to sitagliptin as an add-on treatment to metformin over a period of 24 weeks in obese type 2 diabetic patients younger than 50. Secondary Objectives: To assess the effects of AVE0010 on:
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Detailed Description | Maximum duration of 27 weeks ± 7 days (3-week screening + 24- week double-blind, double-dummy, active-controlled treatment + 3- day follow-up) |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
Condition ICMJE | Type 2 Diabetes Mellitus |
Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 300 | ||||
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Estimated Completion Date | April 2011 | ||||
Estimated Primary Completion Date | April 2011 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | 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. | ||||
Gender | Both | ||||
Ages | 18 Years to 49 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | United States, Australia, Canada, Chile, Mexico, Poland, Romania, Russian Federation, Ukraine |
Administrative Information
NCT ID ICMJE | NCT00976937 | ||||
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Responsible Party | International Clinical Development Study Director, sanofi-aventis | ||||
Study ID Numbers ICMJE | EFC10780, EudraCT:2008-007 334-22 | ||||
Study Sponsor ICMJE | Sanofi-Aventis | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Sanofi-Aventis |