Linjawi Sultan, Sothiratnam Radhakrishna, Sari Ramazan, Andersen Henning, Hiort Line Conradsen, Rao Paturi
Coffs Endocrine and Diabetes Services, Coffs Harbour, New South Wales, Australia.
Columbia Asia Hospital, Seremban, Malaysia.
Prim Care Diabetes. 2015 Oct;9(5):370-6. doi: 10.1016/j.pcd.2014.11.001. Epub 2014 Dec 3.
Investigate efficacy and tolerability of intensifying diabetes treatment with once- or 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.
Open-label, three-arm, 24-week trial; 582 insulin-naïve 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.
After 24 weeks, HbA1c 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; -0.17], P<0.001) and BIAsp BID (BIAsp BID minus BIAsp BID+Sit difference: 0.24 [0.06; 0.43], P=0.01). Observed final HbA1c values were 6.9%, 7.2% and 7.1% (baseline 8.4%), and 59.8%, 46.5% and 49.7% of patients achieved HbA1c <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).
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.
研究在使用西他列汀血糖控制不佳的2型糖尿病（T2D）患者中，加用一日一次或一日两次的双相门冬胰岛素30（BIAsp 30）强化糖尿病治疗的疗效和耐受性，以及不使用西他列汀、一日两次使用BIAsp 30的疗效和耐受性。
开放标签、三臂、24周试验；582例既往未使用过胰岛素的患者被随机分为一日两次BIAsp 30+西他列汀（BIAsp BID+Sit）组、一日一次BIAsp 30+西他列汀（BIAsp QD+Sit）组或不使用西他列汀、一日两次使用BIAsp 30（BIAsp BID）组，所有患者均服用二甲双胍。
24周后，BIAsp BID+Sit组糖化血红蛋白（HbA1c）降低百分比优于BIAsp QD+Sit组（BIAsp BID+Sit组与BIAsp QD+Sit组差值：-0.36 [95%置信区间-0.54；-0.17]，P<0.001）以及BIAsp BID组（BIAsp BID组与BIAsp BID+Sit组差值：0.24 [0.06；0.43]，P=0.01）。观察到的最终HbA1c值分别为6.9%、7.2%和7.1%（基线值8.4%），达到HbA1c<7.0%的患者分别为59.8%、46.5%和49.7%。BIAsp QD+Sit组确诊低血糖发生率低于BIAsp BID组（P=0.015）；发生率：每患者年1.17次（BIAsp QD+Sit组）、1.50次（BIAsp BID+Sit组）和2.24次（BIAsp BID组）。体重变化差异方面，BIAsp QD+Sit组优于两个一日两次用药组（P<0.001）。
在使用西他列汀和二甲双胍血糖控制不佳的T2D患者中加用BIAsp 30是有效且耐受性良好的；然而，虽然BIAsp BID+Sit组血糖控制更佳，但BIAsp QD+Sit组低血糖发生率更低且未出现体重增加。
