Dose Ranging Study of the GLP-1 Agonist AVE0010 in Metformin-Treated Subjects With Type 2 Diabetes Mellitus
Phase 2
Completed
- Conditions
- Type 2 Diabetes
- Registration Number
- NCT00299871
- Lead Sponsor
- Sanofi
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 542
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method HbA1c levels at baseline and endpoint (at 13 weeks).
- Secondary Outcome Measures
Name Time Method Fructosamine, fasting plasma glucose, fasting serum insulin, proinsulin, C-peptide, glucagon.
Trial Locations
- Locations (1)
Sanofi-Aventis Administrative Office
🇺🇦Kiev, Ukraine