Continuous subcutaneous delivery of exenatide via ITCA 650 leads to sustained glycemic control and weight loss for 48 weeks in metformin-treated subjects with type 2 diabetes

Aims: Evaluate the efficacy and tolerability of ITCA 650 in subjects with type 2 diabetes treated for up to 48 weeks. Methods: This was a 24-week extension to a randomized, 24-week, open-label, phase 2 study in subjects with type 2 diabetes inadequately controlled with metformin. Subjects received ITCA 650 mg (20, 40, 60 or 80 mu g/day). Mean changes for HbA1c, weight, and fasting plasma glucose (FPG) were evaluated. Results: Mean changes in HbA1c from baseline to week 48 ranged from -0.85% to -1.51%. At week 48, >= 64% of subjects with an HbA1c <= 7% at week 24 maintained an HbA1c <= 7%. The incidence of adverse events (AEs) was dose-related and ranged from 13.3% with 20 mu g/day to 37.5% with 80 mu g/day. Most AEs were mild and transient; the incidence of nausea declined from 12.9% to 9.5% over the 24-week extension. One subject on ITCA 650 80 mu g/day experienced mild intermittent vomiting. Three (3.5%) subjects experienced severe AEs, but none were considered related to study drug. Conclusion: Significant changes in HbA1c, body weight, and FPG attained with ITCA 650 were maintained to 48 weeks. The incidence of AEs was lower in the 24-week extension than in the initial 24-week treatment phase. Published by Elsevier Inc.