- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00299871
Dose Ranging Study of the GLP-1 Agonist AVE0010 in Metformin-Treated Subjects With Type 2 Diabetes Mellitus
January 27, 2014 updated by: Sanofi
A 13-week Multinational, Randomized, Double-Blind, Placebo-Controlled, Dose-Response Trial Assessing the Safety, Tolerability and Efficacy of AVE0010 in Metformin-Treated Subjects With Type 2 Diabetes Mellitus
To evaluate the dose-response relationship of AVE0010 administered once daily and twice daily with chronic dosing in metformin-treated subjects with type 2 diabetes
Study Overview
Study Type
Interventional
Enrollment (Actual)
542
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Sao Paulo, Brazil
- Sanofi-Aventis Administrative Office
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Laval, Canada
- Sanofi-Aventis Administrative Office
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Warszawa, Poland
- Sanofi-Aventis Administrative Office
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Bucuresti, Romania
- Sanofi-Aventis Administrative Office
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Moscow, Russian Federation
- Sanofi-Aventis Administrative Office
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Kiev, Ukraine
- Sanofi-Aventis Administrative Office
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New Jersey
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Bridgewater, New Jersey, United States, 08807
- Sanofi-Aventis Administrative Office
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Males, females, age 30, - 75 years, type 2 diabetes mellitus, treated with metformin ≥1.0 g/day, at a stable dose for at least 3 months, BMI 25 - 40 kg/m2, HbA1C ≥7.0% and <9.0%.
Exclusion Criteria:
- Type 1 diabetes, pregnancy, lactation, women of childbearing potential, treatment with other antidiabetic agents than metformin, history of metabolic acidosis, hemoglobinopathy or hemolytic anemia, clinically significant medical abnormalities.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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HbA1c levels at baseline and endpoint (at 13 weeks).
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Secondary Outcome Measures
Outcome Measure |
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Fructosamine, fasting plasma glucose, fasting serum insulin, proinsulin, C-peptide, glucagon.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2006
Primary Completion (Actual)
August 1, 2007
Study Completion (Actual)
August 1, 2007
Study Registration Dates
First Submitted
March 6, 2006
First Submitted That Met QC Criteria
March 6, 2006
First Posted (Estimate)
March 7, 2006
Study Record Updates
Last Update Posted (Estimate)
January 28, 2014
Last Update Submitted That Met QC Criteria
January 27, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DRI6012
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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