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

ABSTRACT

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.