脱胶胰岛素
医学
胰岛素
糖尿病
2型糖尿病
内科学
内分泌学
析因分析
甘精胰岛素
作者
Yijun Li,Soumitra Kar,Congcong Li,Ming Rong Liu,Zijian Luan,Guoyue Yuan,Xing Zhong,Yiming Mu
出处
期刊:Diabetes Therapy
[Adis, Springer Healthcare]
日期:2025-02-28
卷期号:16 (4): 685-699
被引量:5
标识
DOI:10.1007/s13300-025-01701-2
摘要
This post hoc analysis evaluated subgroup data from China (Chinese mainland, n = 100; Taiwan, n = 45) in ONWARDS 3, a 26-week, randomized, double-blind, double-dummy, treat-to-target, phase 3a trial comparing the efficacy and safety of once-weekly insulin icodec (icodec) versus once-daily insulin degludec (degludec) in insulin-naive participants with type 2 diabetes (T2D). Adults were randomized 1:1 to icodec and once-daily placebo (icodec; n = 72) or degludec and once-weekly placebo (degludec; n = 73). The primary endpoint was change in glycated hemoglobin (HbA 1c ) (baseline to week 26). Secondary assessments included change in fasting plasma glucose (FPG; baseline to week 26); total weekly insulin dose (weeks 24–26); body weight change (baseline to week 26); and clinically significant or severe hypoglycemia rates (baseline to week 31 [5-week follow-up included]). At week 26, from baseline values of 8.22% (icodec) and 8.39% (degludec), estimated mean changes in HbA 1c were − 1.38% points and − 1.10% points, respectively (estimated treatment difference [95% confidence interval], − 0.28%-points [− 0.50%-points, − 0.05%-points]; p = 0.0152). For icodec and degludec, estimated mean FPG change (− 2.3 mmol/L vs. − 2.3 mmol/L), estimated mean insulin doses (158 U/week vs. 142 U/week), and estimated body weight change (2.5 kg vs. 2.4 kg) were similar. Combined clinically significant or severe hypoglycemia rates were low (0.10 [icodec] vs. 0.07 [degludec] events per patient-year of exposure), with no statistically significant difference between groups. In insulin-naive Chinese individuals with T2D, once-weekly icodec treatment showed significantly greater HbA 1c reductions after 26 weeks than once-daily degludec, with low combined clinically significant or severe hypoglycemia rates across groups. NCT04795531.
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