AIM To compare the efficacy and safety of Gla-300 versus Gla-100 in insulin-naïve people with type 2 diabetes in Asia Pacific. MATERIALS AND METHODS In this open-label, randomized, active-controlled, 26-week study, insulin-naïve participants with type 2 diabetes inadequately controlled with non-insulin antihyperglycaemic drugs were randomized (2:1) to Gla-300 or Gla-100. The initial daily dose of basal insulin was 0.2 U/kg and was adjusted at least weekly for 8-12 weeks to a target fasting self-monitored plasma glucose (SMPG) of 4.4-5.6 mmol/L. RESULTS Of the 604 participants randomized, 570 (Gla-300, n = 375; Gla-100, n = 195) completed the study. Non-inferiority of Gla-300 versus Gla-100 in HbA1c reduction from baseline to week 26 was confirmed. In the Gla-300 and Gla-100 groups, 51.1% and 52.2% of participants achieved the HbA1c target of <7.0% (rate ratio [95% CI]: 0.98 [0.84 to 1.14]) and 19.1% and 21.9% achieved the target without hypoglycaemia during the last 12 weeks of treatment (rate ratio [95% CI]: 0.87 [0.63 to 1.20]). Changes in fasting plasma glucose and 24-hour average eight-point SMPG were comparable between groups. Incidence of hypoglycaemia at any time of day was similar between treatment groups at week 26, but incidence of any nocturnal hypoglycaemia was numerically lower with Gla-300 than Gla-100 over the initial 12-week titration period and 26-week on-treatment period. Rates of adverse events were similar between groups and low for serious adverse events. CONCLUSIONS Glycaemic control of Gla-300 is non-inferior to Gla-100 with a similar or lower incidence and proportion of hypoglycaemia in people with type 2 diabetes in Asia Pacific, reinforcing the results in the global EDITION programme.

中文翻译：

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在亚太地区未接受过胰岛素治疗的2型糖尿病患者中，甘精胰岛素300 U / mL与甘精胰岛素100 U / mL的疗效和安全性：EDITION AP随机对照试验。

目的比较Gla-300和Gla-100在未接受胰岛素治疗的2型糖尿病亚太地区的疗效和安全性。材料与方法在这项开放性，随机，活动，对照，为期26周的研究中，未接受非胰岛素降血糖药控制不充分的2型糖尿病初治参与者被随机分配（2：1）入Gla-300或Gla- 100 基础胰岛素的初始每日剂量为0.2 U / kg，并且至少每周调整一次，持续8-12周，以达到4.4-5.6 mmol / L的目标空腹自我监测血浆葡萄糖（SMPG）。结果在604位随机参与者中，有570位（Gla-300，n = 375； Gla-100，n = 195）完成了研究。从基线到第26周，确认了Gla-300与Gla-100相比HbA1c降低的非劣效性。在Gla-300和Gla-100组中，有51.1％和52.2％的参与者达到了< 7.0％（比率[95％CI]：0.98 [0.84至1.14]）和19.1％和21.9％在治疗的最后12周达到了无低血糖的目标（比率[95％CI]：0.87 [0.63至1.20] ]）。两组之间空腹血糖和24小时平均八点SMPG的变化相当。治疗组在第26周时，一天中任何时间的低血糖发生率相似，但在最初的12周滴定期间和治疗的26周期间，使用Gla-300的任何夜间低血糖的发生率均在数值上低于Gla-100。 。两组之间的不良事件发生率相似，严重不良事件发生率较低。结论在亚太地区2型糖尿病患者中，Gla-300的血糖控制能力不亚于Gla-100，其低血糖的发生率和比例相同或更低。