Department of Metabolism and Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan.
Novo Nordisk A/S, Søborg, Denmark.
Diabetes Obes Metab. 2024 Dec;26(12):5882-5895. doi: 10.1111/dom.15960. Epub 2024 Sep 30.
To explore the efficacy and safety of once-weekly insulin icodec (icodec) in Japanese adults (≥20 years old) with type 2 diabetes from the global ONWARDS 1, 2 and 4 trials.
Insulin-naive (ONWARDS 1) and insulin-experienced (ONWARDS 2 and 4) individuals were randomized to icodec or a once-daily insulin comparator: insulin glargine U100 [ONWARDS 1 (basal insulin only) and 4 (basal-bolus regimen)] or insulin degludec [ONWARDS 2 (basal insulin only)]. The primary outcome was change in glycated haemoglobin from baseline to end of treatment (EOT) (ONWARDS 1: Week 52; ONWARDS 2 and 4: Week 26). Here, we present the Japanese subgroup results.
Similar reductions in glycated haemoglobin from baseline to EOT were observed in each trial for icodec and comparators. The proportion of time in range (blood glucose 3.9-10.0 mmol/L) at EOT was also comparable across treatment groups (time in range: 58%-68%), as was time spent with blood glucose below 3.0 mmol/L (<1.0%). Combined clinically significant (blood glucose <3.0 mmol/L) or severe (requiring external assistance for recovery) hypoglycaemia rates were low, with no severe events (ONWARDS 1 and 2) or a single severe event (ONWARDS 4; icodec group) reported. These results generally aligned with findings from the respective global populations. No new safety issues were identified.
Icodec improved glycaemic control to a similar degree as once-daily basal insulin comparators while maintaining low levels of clinically significant or severe hypoglycaemia. The findings support icodec use in Japanese individuals with different levels of type 2 diabetes progression.
探索每周一次胰岛素icodec（icodec）在来自全球 ONWARDS 1、2 和 4 试验的 2 型糖尿病日本成年患者（≥20 岁）中的疗效和安全性。
胰岛素初治（ONWARDS 1）和胰岛素经验丰富（ONWARDS 2 和 4）个体随机接受 icodec 或每日一次胰岛素对照剂：甘精胰岛素 U100 [ONWARDS 1（仅基础胰岛素）和 4（基础-餐时胰岛素方案）]或德谷胰岛素 [ONWARDS 2（仅基础胰岛素）]。主要结局是从基线到治疗结束（EOT）时糖化血红蛋白的变化（ONWARDS 1：第 52 周；ONWARDS 2 和 4：第 26 周）。在这里，我们呈现了日本亚组的结果。
在每个试验中，icodec 和对照剂从基线到 EOT 均观察到糖化血红蛋白相似的降低。EOT 时的血糖达标时间（血糖 3.9-10.0mmol/L）也在各个治疗组之间具有可比性（达标时间：58%-68%），血糖低于 3.0mmol/L（<1.0mmol/L）的时间也相似。低血糖的综合临床显著（血糖<3.0mmol/L）或严重（需要外部帮助恢复）发生率较低，没有严重事件（ONWARDS 1 和 2）或单个严重事件（ONWARDS 4；icodec 组）报告。这些结果与各自的全球人群的发现基本一致。未发现新的安全问题。
icodec 改善血糖控制的程度与每日一次基础胰岛素对照剂相似，同时保持较低的临床显著或严重低血糖发生率。这些发现支持在不同 2 型糖尿病进展程度的日本个体中使用 icodec。
