Results presented at the 2014 American Diabetes Association Scientific Sessions, demonstrated that patients with severe hyperglycemia and longstanding type 2 diabetes treated with ITCA 650 (continuous subcutaneous delivery of exenatide; Intarcia Therapeutics) had marked improvements in glycemic control, according to the first 6-month data from an ongoing open-label Phase 3 trial.
The data included the first 6-month, open-label experience with ITCA 650 mini-pumps from an ongoing multicenter study in subjects with type 2 diabetes who did not meet enrollment criteria for the double-blind placebo controlled trial because their HbA1C was >10%. A total of 60 patients who met all of the qualifications for the double-blind study except for elevated blood sugar levels and an HbA1C between 10-12% were enrolled.
Treatment was initiated by placing a 3-month ITCA 650 mini-pump delivering 20 mcg/day, which was then replaced by a 6-month ITCA 650 mini-pump delivering 60 mcg/day for 26 weeks. Pre-study oral anti-diabetic agents were maintained unchanged for the 39 weeks of treatment. The primary endpoint in the trial is change in HbA1C from baseline to week 39.
At the time of the initial interim analysis, 50 patients completed 13 weeks, 39 patients completed 19 weeks, and 25 patients completed 26 weeks. Mean reductions of HbA1C at Weeks 13 (n=50), 19 (n=39), and 26 (n=25) were -2.5%, -2.9%, and -3.2%, respectively. HbA1C reductions ≥2% were achieved by 78% of subjects who completed at least 13 weeks of treatment; 50% achieved >3% and 22% achieved ≥4% reductions. HbA1C targets of <7% were achieved in 26% of subjects who had completed at least 13 weeks of treatment.
ITCA 650 an investigational therapy, utlizes Intarcia’s proprietary technology platform involving a matchstick-size, miniature osmotic pump that is inserted sub-dermally to provide continuous and consistent drug therapy, and the company’s proprietary formulation technology, which maintains stability of therapeutic proteins and peptides at human body temperatures for long extended periods of time. Exenatide, the active agent in ITCA 650, is a glucagon-like peptide-1 (GLP-1) receptor agonist currently approved as a twice-daily and once weekly self-injection therapy for type 2 diabetes.
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