Dose Ranging Study of the GLP-1 Agonist AVE0010 in Metformin-Treated Subjects With Type 2 Diabetes Mellitus

• Status: Completed
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Lixisenatide; Metformin

Criteria

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.