ITCA 650 consists of a small titanium osmotic mini-pump that is subdermally placed in the abdominal wall during a brief office procedure. As an investigational product for the treatment of type 2 diabetes (T2D), ITCA 650 provides a continuous subcutaneous infusion of exenatide over 3 or 6 months. An integrated analysis of efficacy and safety was conducted from 2 double-blind, randomized, Phase 3 studies, which evaluated pooled data with ITCA 650 20/60 mcg/d vs. placebo or sitagliptin for the treatment of patients with T2D, inadequately controlled on antidiabetic drugs. The efficacy endpoints were mean change from baseline at Week 39 for HbA1c, body weight, composite endpoints of HbA1c and weight loss, and proportion achieving HbA1c <7%. The incidence of treatment-emergent adverse events (TEAEs) was also reported. Significant and clinically meaningful improvements at 39 weeks were observed with ITCA 650 20/60 mcg/d for all these endpoints. The higher incidence of TEAEs with ITCA 650 vs. comparators was explained by the higher incidence of GI TEAEs. Similar proportions of patients in each group discontinued for TEAEs. The results are consistent with results observed from individual Phase 3 studies, which demonstrated that ITCA 650 is effective for lowering HbA1c and weight, for achieving a composite of HbA1c/weight reduction and target HbA1c <7%, and is well tolerated.
L.L. Kjems: Employee; Self; Intarcia Therapeutics, Inc.. Stock/Shareholder; Self; Intarcia Therapeutics, Inc.. P. Prabhakar: None. B. Schwartz: Employee; Self; Intarcia Therapeutics, Inc.. H. Huang: None. M.A. Baron: Employee; Self; Intarcia Therapeutics, Inc..