Taneda Shinji, Hyllested-Winge Jacob, Gall Mari-Anne, Kaneko Shizuka, Hirao Koichi
Diabetes Center, Manda Memorial Hospital, Hokkaido, Japan.
Novo Nordisk Pharma Ltd, Tokyo, Japan.
J Diabetes. 2017 Mar;9(3):243-247. doi: 10.1111/1753-0407.12407. Epub 2016 Jul 7.
The present study was a subgroup analysis of a Pan-Asian Phase 3 open-label randomized treat-to-target trial evaluating insulin degludec/insulin aspart (IDegAsp) and biphasic insulin aspart 30 (BIAsp 30) in Japanese subjects with type 2 diabetes inadequately controlled on insulin.
Eligible subjects (n = 178) were randomized (2: 1) to twice-daily (b.i.d.) IDegAsp or BIAsp 30 with or without metformin for 26 weeks, titrated to a blood glucose target of between 3.9 and <5.0 mmol/L. Changes in HbA , the proportion of responders reaching the HbA target, and changes in fasting plasma glucose, nine-point self-monitored plasma glucose profiles, and body weight were assessed.
At 26 weeks, the decrease in HbA was similar in both groups. Fasting plasma glucose was lower with IDegAsp than BIAsp 30 (estimated treatment difference -1.50 mmol/L; 95 % confidence interval [CI] -1.98, -1.01). Overall confirmed hypoglycemia rates were similar; the nocturnal confirmed hypoglycemia rate was lower with IDegAsp than BIAsp 30 (estimated rate ratio 0.44; 95 % CI 0.20, 0.99). No severe hypoglycemic episodes were reported.
The results indicate that IDegAsp b.i.d. improves glycemic control and, compared with BIAsp 30, lowers the rate of nocturnal confirmed hypoglycemia.
本研究是一项泛亚3期开放标签随机治疗达标试验的亚组分析，该试验在胰岛素治疗血糖控制不佳的日本2型糖尿病患者中评估德谷胰岛素/门冬胰岛素（IDegAsp）和门冬胰岛素30双相制剂（BIAsp 30）。
符合条件的受试者（n = 178）被随机分组（2:1），接受每日两次（bid）的IDegAsp或BIAsp 30治疗，联合或不联合二甲双胍，治疗26周，滴定至血糖目标值为3.9至<5.0 mmol/L。评估糖化血红蛋白（HbA）的变化、达到HbA目标的应答者比例、空腹血糖、九点自我监测血糖谱和体重的变化。
在26周时，两组的HbA降低情况相似。IDegAsp组的空腹血糖低于BIAsp 30组（估计治疗差异为-1.50 mmol/L；95%置信区间[CI]为-1.98，-1.01）。总体确认低血糖发生率相似；IDegAsp组的夜间确认低血糖发生率低于BIAsp 30组（估计发生率比为0.44；95%CI为0.20，0.99）。未报告严重低血糖事件。
结果表明，每日两次的IDegAsp可改善血糖控制，与BIAsp 30相比，并降低夜间确认低血糖的发生率。
