A Study to Evaluate ITCA 650 Compared to Glimepiride as Add on Therapy for the Treatment of Type 2 Diabetes

A Phase 3, Randomized, Active Comparator, Double-Blind, Multi-Center Study to Compare the Efficacy, Safety and Tolerability of ITCA 650 to Glimepiride as Add-on Therapy to Metformin in Patients With Type 2 Diabetes

Phase 3 study to examine treatment with ITCA 650 compared to glimepiride when added to metformin monotherapy in reducing HbA1c in patients with type 2 diabetes.

Inclusion Criteria:

• HbA1c between 7.5% - 10.5%
• on metformin monotherapy
• BMI between 25 & 45 kg/m2

Exclusion Criteria:

• On thiazolidinedione, sulfonylurea, DPP-4, alpha glucosidase inhibitor, meglitinides or insulin within last 3 months
• history of pancreatitis