ITCA 650 (exenatide) osmotic pump safety evaluated in Type 2 Diabetes patients switching from liraglutide

Managing Type 2 Diabetes Mellitus (T2DM) often requires long-term adherence to complex medication regimens. Glucagon-like peptide-1 receptor (GLP-1R) agonists like liraglutide are effective for glycemic control and weight management, but require daily injections. Sustained-release formulations, such as the ITCA 650 osmotic mini pump delivering exenatide, aim to improve patient adherence and convenience by providing continuous drug delivery over extended periods. This study addresses the clinical gap of safely transitioning patients from existing daily GLP-1R agonist therapy to a less frequent, continuous-delivery system.

This open-label, randomized, multicenter, Phase 3b study enrolled 136 patients with Type 2 Diabetes who were receiving stable doses of liraglutide (at least 1.2 mg/day) and metformin (at least 1000 mg/day). Participants were randomized to switch to one of two dosing strategies of ITCA 650 (exenatide) delivered via an osmotic mini pump: either 20/60 mcg/day (titrated) or 60 mcg/day. The primary objective was to evaluate the safety and tolerability of this switch, monitoring adverse events and other safety parameters.