Patients with type 2 diabetes that is not adequately controlled using oral antidiabetes drugs may someday have a new option with a combination drug-device product, ITCA 650, which consists of an osmotic minipump that delivers a continuous subcutaneous infusion of exenatide for extended periods, according to a phase 3 study (ClinicalTrials.gov identifier: NCT01455857) published in Diabetes Care.
Researchers from 126 clinical sites in the United States randomly assigned 460 patients age 18 to 80 years who had glycated hemoglobin (HbA1c) levels of 7.5% to 10% (58-86 mmol/mol) to receive either ITCA 650 40 µg/day (n=153), ITCA 650 60 µg/day (n=153), or placebo (n=154) for 39 weeks.
ITCA 650 reduced HbA1c levels significantly, with a mean change from baseline of -1.1% (-12.2 mmol/mol) and -1.2% (-13.2 mmol/mol) for patients in the ITCA 650 40 and 60 µg/day groups, respectively (P <.001 vs placebo -0.1% [-1.3 mmol/mol]). By week 39, an HbA1c level of less than 7% (53 mmol/mol) had been reached in 37%, 44%, and 9% of patients in the ITCA 650 40 µg/day, ITCA 650 60 µg/day, and placebo groups, respectively (P <.001 for each dose vs placebo).
ITCA 650 also reduced body weight significantly, with a mean change from baseline of -2.3 kg and -3.0 kg for patients in the ITCA 650 40 and 60 µg/day groups, respectively (P ≤.015 vs placebo -1.0 kg). ITCA 650 was well tolerated. Nausea was the most common adverse event, however, it subsided over time.
ITCA 650 is the first injection-free glucagon-like peptide 1 receptor agonist, and this was the first large controlled study to demonstrate its efficacy and safety for patients with type 2 diabetes. The investigators concluded that, “This integrated drug-device combination maintains long-term effective blood concentrations of exenatide and has the ability to ensure medication adherence and lead to sustained glycemic control and weight loss.”
Rosenstock J, Buse JB, Azeem R, et al. Efficacy and safety of ITCA 650, a novel drug-device GLP-1 receptor agonist, in type 2 diabetes uncontrolled with oral antidiabetes drugs: the FREEDOM-1 trial [published online December 14, 2017]. Diabetes Care. doi: 10.2337/dc17-1306