OBJECTIVE This post hoc analysis assessed continuous glucose monitoring (CGM)–based metrics and hypoglycemia duration with once-weekly insulin icodec versus once-daily basal insulin analogs in insulin-experienced individuals with long-standing type 2 diabetes from two 26-week phase 3a trials (ONWARDS 2 and ONWARDS 4). RESEARCH DESIGN AND METHODS Time in range (TIR) (3.9–10.0 mmol/L), time above range (TAR) (>10.0 mmol/L), and time below range (TBR) (<3.9 mmol/L and <3.0 mmol/L) were assessed during three CGM time periods (switch [weeks 0–4], end of treatment [weeks 22–26], and follow-up [weeks 27–31]) for icodec versus comparators (ONWARDS 2, insulin degludec [basal regimen]; ONWARDS 4, insulin glargine U100 [basal-bolus regimen]) using double-blind CGM data. CGM-derived hypoglycemic episode duration (<3.9 mmol/L) was assessed. RESULTS In both trials, there were no statistically significant differences in TIR, TAR, or TBR (<3.0 mmol/L) for icodec versus comparators across all time periods. In the end-of-treatment period, mean TIR was 63.1% (icodec) vs. 59.5% (degludec) in ONWARDS 2 and 66.9% (icodec) vs. 66.4% (glargine U100) in ONWARDS 4. Mean TBR <3.9 mmol/L and <3.0 mmol/L remained within recommended targets (<4% and <1%, respectively) across time periods and treatment arms. Hypoglycemic episode duration (<3.9 mmol/L) was comparable across time periods and treatment arms (median duration ≤40 min). CONCLUSIONS In insulin-experienced participants with long-standing type 2 diabetes, CGM-based TIR, TAR, and CGM-derived hypoglycemia duration (<3.9 mmol/L) were comparable for icodec and once-daily basal insulin analogs during all time periods. TBR remained within recommended targets.

中文翻译：

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长期使用胰岛素的 2 型糖尿病患者的基于连续血糖监测的指标和低血糖持续时间从每日基础胰岛素改为每周一次胰岛素 Icodec：ONWARDS 2 和 ONWARDS 4 的事后分析

目的 这项事后分析评估了患有长期 2 型糖尿病的长期 2 型糖尿病患者在两次 26 周 3a 阶段中使用每周一次胰岛素 icodec 与每日一次基础胰岛素类似物的基于连续血糖监测 (CGM) 的指标和低血糖持续时间试验（ONWARDS 2 和 ONWARDS 4）。研究设计和方法 时间范围内 (TIR) (3.9–10.0 mmol/L)、时间高于范围 (TAR) (>10.0 mmol/L) 和时间低于范围 (TBR)（<3.9 mmol/L 和 < ;3.0 mmol/L）在三个 CGM 时间段（切换[第 0-4 周]、治疗结束[第 22-26 周]和随访[第 27-31 周]）期间对 icodec 与比较剂进行了评估（ONWARDS 2 ，德谷胰岛素 [基础方案]；ONWARDS 4，甘精胰岛素 U100 [基础推注方案]）使用双盲 CGM 数据。评估CGM衍生的低血糖发作持续时间(＜3.9mmol/L)。结果 在这两项试验中，在所有时间段内，icodec 与比较药物的 TIR、TAR 或 TBR (<3.0 mmol/L) 没有统计学上的显着差异。在治疗结束时，ONWARDS 2 中的平均 TIR 为 63.1%（icodec）对比 59.5%（德谷），ONWARDS 4 中平均 TIR 为 66.9%（icodec）对比 66.4%（甘精胰岛素）。平均 TBR <3.9 mmol/L 和<3.0 mmol/L 在各个时间段和治疗组中均保持在推荐目标范围内（分别<4% 和<1%）。低血糖发作持续时间(＜3.9mmol/L)在不同时间段和治疗组之间具有可比性(中位持续时间≤40分钟)。结论 在使用过胰岛素的长期 2 型糖尿病参与者中，在所有时间段内，基于 CGM 的 TIR、TAR 和 CGM 衍生的低血糖持续时间 (<3.9 mmol/L) 与 icodec 和每日一次基础胰岛素类似物相当。TBR 仍保持在建议目标之内。