DRUG
Dose Ranging Study of the GLP-1 Agonist AVE0010 in Metformin-Treated Subjects With Type 2 Diabetes Mellitus
Status
Completed
Phase
Phase 2
Enrollment
542
Locations
7
Results
Not posted
Publications
1
Study summary
What the protocol is testing.
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
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Mar 7, 2006
Study start
Feb 2006
Primary completion
Aug 2007
Study completion
Aug 2007
Results posted
Not reported
Registry updated
Jan 28, 2014
Outcomes
What the study measures.
Primary outcomes
HbA1c levels at baseline and endpoint (at 13 weeks).
Secondary outcomes
Fructosamine, fasting plasma glucose, fasting serum insulin, proinsulin, C-peptide, glucagon.
Eligibility
Who can take part.
- Minimum age
- 30 Years
- Maximum age
- 75 Years
- Sex
- ALL
- Healthy volunteers
- No
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 locations
7 registered sites.
Brazil · Canada · Poland · Romania · Russia · Ukraine · United States. Showing up to 24 locations stored in the fast local snapshot.
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States
Sanofi-Aventis Administrative Office
São Paulo, Brazil
Sanofi-Aventis Administrative Office
Laval, Canada
Sanofi-Aventis Administrative Office
Warsaw, Poland
Sanofi-Aventis Administrative Office
Bucharest, Romania
Sanofi-Aventis Administrative Office
Moscow, Russia
Sanofi-Aventis Administrative Office
Kiev, Ukraine
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