ITCA 650 consists of a small titanium osmotic mini—pump that is subdermally placed in the abdominal wall during a brief in-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. Pooled 39-week data from two double-blind, randomized, Phase 3 studies were used to evaluate the efficacy of ITCA 650 20/60 mcg/d in patients with T2D inadequately controlled by oral antidiabetic drugs (OADs). Results in the overall population (N=683) and in subgroups according to age, gender, BMI, ethnicity, time since diagnosis, baseline HbA1c, GI adverse events, presence of anti-drug antibodies, and renal function are reported. As shown in the Figure, the overall mean (standard deviation [SD]) reduction in HbA1c (%) was 1.5% (1.2) with clinically meaningful reductions in HbA1c consistently observed irrespective of age, gender, BMI, ethnicity, time from T2D diagnosis, eGFR and background OADs (data not shown). Patients with a higher baseline HbA1c had a greater response. Mean weight loss was 3.4 kg (SD 4.7), and 40.7% (95% CI 0.36-0.46) of patients achieved a composite endpoint of HbA1c/weight reduction of >0.5%/≥2 kg. Similar changes were likewise seen consistently across subgroups. ITCA 650 demonstrated consistent efficacy across a wide spectrum of patients with T2D.
P. Prabhakar: None. L.L. Kjems: Employee; Self; Intarcia Therapeutics, Inc.. Stock/Shareholder; Self; Intarcia Therapeutics, Inc.. H. Huang: None. B. Schwartz: Employee; Self; Intarcia Therapeutics, Inc. M.A. Baron: Employee; Self; Intarcia Therapeutics, Inc..
