Striking Clinical Trial Results from Intarcia’s Implanted Type 2 Diabetes Device

This evening, Intarcia just announced exciting results for ITCA 650, a small implanted device to treat type 2 diabetes. The tiny device is implanted under the skin just once or twice a year in a quick procedure (within a matter of minutes!) and continuously releases exenatide (a GLP-1 agonist) through a small mini-pump the size of a matchstick (see photo). The “FREEDOM-2” trial compared ITCA 650 to the DPP-4 inhibitor pill Januvia, both in addition to metformin, in people with type 2 diabetes. The results? Patients treated with ITCA 650 had significantly greater A1c reductions (1.5% vs. 0.8%) and weight loss (4 kg vs. 1.3 kg, or roughly 9 pounds vs. 3 pounds) compared to those on Januvia after 52 weeks. As diaTribe Advisory Board member Dr. John Buse states, “ITCA 650 is an exciting product based on efficacy and particularly for the large proportion of the population that [struggles with] daily self-care, specifically in the medication and monitoring areas.”

ITCA 650 should be submitted to the FDA in the first half of 2016, meaning it could be on the market as early as 2017 depending on how the FDA review goes. The company is more than on track, and these results today came a month earlier than expected! These combined results of a 1.5% A1c drop and a 9 pound weight loss are quite striking – if approved, this therapy could be a complete game-changer for the treatment of type 2 diabetes and the use of GLP-1 agonist drugs in particular. Indeed, as Nancy Thornberry – inventor of Januvia(!) – told us, “The magnitude of the glycemic control and weight loss demonstrated with ITCA 650 in the FREEDOM-2 study, together with the innovative delivery system with once or twice yearly dosing, suggest that this approach has the potential to be transformational for patients with type 2 diabetes.”

For more background on Intarcia’s ITCA 650 therapy, please see our past coverage here. -AJW/KC/ER