The program will include over 3,000 diabetic patients and will evaluate a once-a-day injection of AVE0010/ZP10 in combination with the principal existing treatments (metformin, sulfonylurea, insulin), as well as a comparison with exenatide and a monotherapy study.
Filing for approval is expected in 2010. A prolonged release formulation is currently being evaluated in Phase I. AVE0010/ZP10 is a glucagon-like peptide 1, or ‘GLP-1’, receptor agonist developed for subcutaneous injection treatment of Type 2 diabetes and incorporates Zealand Pharma’s ‘SIP’ technology.