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Investigational Drug ITCA 650, a GLP-1 Receptor Agonist, on the Way

Drug shows a significant reduction in HbA1c in patients with type 2 diabetes…

A new investigational drug is underway to help with reduction of HbA1c, weight, and improve glycemic control in type 2 diabetes patients. ITCA 650 is an injection-free GLP-1 receptor agonist that provides continuous subcutaneous exenatide for 12 months using a subdermal placement. According to the data presented at the American Diabetes Association, ITCA 650 show excellent results in patients who are having problems with glycemic control.

See more GLP-1 Agonist Resources

The study was done using a placebo-controlled, double-blind, phase 3 FREEDOM-1 trial with 460 patients with type 2 diabetes whose HbA1c was not controlled by antidiabetic medications, diet, or exercise. They were assigned to treatment ITCA 650 40mcg daily, ITCA 650 60mcg daily or placebo. For 13 weeks they started with 20mcg and progressed to 40mcg or 60mcg daily for 26 weeks. At week 39 the reduction of HbA1c at baseline was 1.1% (97.5% CI, –1.29 to –0.71) with ITCA 650 40 mcg and 1.2% (97.5% CI, –1.37 to –0.80) with ITCA 650 60 mcg. Also, patients not taking sulfonylureas showed a greater reduction in HbA1c of 1.7%. The most common adverse effect was gastrointestinal and skin irritation.

Results from the FREEDOM-1 HBL trial were also presented. The trial had 60 patients with a mean HbA1c of 10.8% and mean BMI of 32 and diabetes duration of 9 years. The patients were treated with ITCA 650 20mcg daily for 13 weeks and ITCA 650 60mcg for the next 26 weeks. At week 6, a greater reduction in HbA1c was seen and the change from baseline was sustained over time. At week 39, mean reduction was 3.4%, and 22% of patients had achieved reductions of at least 4%. Additionally, 22% of patients achieved a target HbA1c of less than 7%.

Robert Henry, chief of VA Endocrinology & Metabolism and professor of medicine in residence at the University of California, San Diego, commented in a press release, “I am very pleased with these phase 3 results. ITCA 650 delivered excellent results for such a high-risk and refractory patient population — and all of this without the need for regular self-injections. I think these new data indicate that the ITCA 650 method of delivery may provide an uninterrupted, smooth and continuous dose that delivers powerful reductions in HbA1c without the need for patient action in terms of managing their medication.”

Practice Pearls:

  • ITCA 650 yielded significant reduction in HbA1c, weight, and improved glycemic control in patients with type 2 diabetes.
  • In the study weight loss appeared to be dose dependent over 39 weeks using ITCA 650 60mcg.
  • The phase 3 trial results suggest that ITCA 650 has the potential to open up doors for new treatment to help address the needs and adherence in patients with type 2 diabetes.

Presented at the ADA 75th Scientific Sessions June 2015 “ITCA 650 Safe, Effective in Type 2 Diabetes.”