Treatment satisfaction with ITCA 650, a novel drug‐device delivering continuous exenatide, versus twice‐daily injections of exenatide in type 2 diabetics using metformin

Aims To evaluate treatment satisfaction in patients with type 2 diabetes (T2D) not adequately controlled by metformin, randomized to ITCA 650 (continuous exenatide in osmotic mini‐pump) vs twice‐daily exenatide injections (Ex‐BID). Materials and methods The Diabetes Medication Satisfaction Tool (DM‐SAT) was administered and assessments were made at baseline, Week 8 and Week 20 during a 24‐week open‐label phase 2 trial. In Stage I (Weeks 1‐12), 155 patients, comprising the ITT population, were randomized to 3 groups: ITCA 650 20 μg/day, ITCA 650 40 μg/day and Ex‐BID 10 μg BID. In Stage II (Weeks 13‐24), ITCA 650 groups were re‐randomized to either remain on the Stage I dose or receive a higher dose. Patients treated with Ex‐BID were randomized to 40 or 60 μg/day ITCA 650. Results Patients using ITCA 650 reported significant increases in overall treatment satisfaction by Week 8 vs those using Ex‐BID ( P < .01), despite similar clinical efficacy and overall rates of nausea. During Stage II, further improvement in HbA1c and weight were seen after 3‐fold dose escalation of ITCA 650 and treatment satisfaction was maintained. When patients using Ex‐BID were switched to ITCA 650, treatment satisfaction increased and reached levels similar to those initially treated with ITCA 650. Neither GI side effects of nausea and/or vomiting, nor the procedure to sub‐dermally place ITCA 650, significantly impacted treatment satisfaction scores. Conclusion ITCA 650 added to metformin for patients with T2D, and for those who switched to ITCA 650 from Ex‐BID, meaningfully improved glucose control and significantly increased overall treatment satisfaction.