A Study to Evaluate ITCA 650 Compared to Sitagliptin 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 Sitagliptin as Add-on Therapy to Metformin in Patients With Type 2 Diabetes

Phase 3 study to compare treatment with ITCA 650 to sitagliptin when added to metformin monotherapy in patients with type 2 diabetes.

Inclusion Criteria:

• HbA1c between 7.5%-10%
• on metformin monotherapy
• BMI between 25 & 45 kg/m2

Exclusion Criteria:

• taking thiazolidinedione, sulfonylurea, DPP-4, exenatide, alpha glucosidase inhibitors, meglitinides or insulin within last 3 months
• history of pancreatitis