The study of once- and twice-daily biphasic insulin aspart 30 (BIAsp 30) with sitagliptin, and twice-daily BIAsp 30 without sitagliptin, in patients with type 2 diabetes uncontrolled on sitagliptin and metformin-The Sit2Mix trial

Aims: Investigate efficacy and tolerability of intensifying diabetes treatment with onceor twice-daily biphasic insulin aspart 30 (BIAsp 30) added to sitagliptin, and twice-daily BIAsp 30 without sitagliptin in patients with type 2 diabetes (T2D) inadequately controlled on sitagliptin. Methods: Open-label, three-am, 24-week trial; 582 insulin-na ve patients were randomized to twice-daily BIAsp 30 + sitagliptin (BIAsp BID + Sit), once-daily BIAsp 30 + sitagliptin (BIAsp QD + Sit) or twice-daily BIAsp 30 without sitagliptin (BIAsp BID), all with metformin. Results: After 24 weeks, HbA(1c) reduction (%) was superior with BIAsp BID + Sit vs. BIAsp QD + Sit (BIAsp BID + Sit minus BIAsp QD + Sit difference: -0.36 [95% CI -0.54; -0.171, P < 0.001) and BIAsp BID (BIAsp BID minus BIAsp BID + Sit difference: 0.24 [0.06; 0.43], P.= 0.01). Observed final HbAi, values were 6.9%, 7.2% and 7.1% (baseline 8.4%), and 59.8%, 46.5% and 49.7% of patients achieved HbA(1c) < 7.0%, respectively. Confirmed hypoglycaemia was lower with BIAsp QD + Sit vs. BIAsp BID (P = 0.015); rate: 1.17 (BIAsp QD + Sit), 1.50 (BIAsp BID + Sit) and 2.24 (BIAsp BID) episodes/patient-year. Difference in bodyweight change favoured BIAsp QD + Sit vs. both BID groups (P < 0.001). Conclusions: Adding BIAsp 30 to patients with T2D poorly controlled with sitagliptin and metformin is efficacious and well tolerated; however, while BIAsp BID + Sit showed superior glycaemic control, BIAsp QD + Sit had a lower rate of hypoglycaemia and showed no weight gain. (C) 2014 Primary Care Diabetes Europe. Published by Elsevier Ltd. All rights reserved.