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Introduction <p>This post hoc analysis evaluated subgroup data from China (Chinese mainland, <i>n</i> = 100; Taiwan, <i>n</i> = 45) in ONWARDS&#xa0;3, a 26-week, randomized, double-blind, double-dummy, treat-to-target, phase&#xa0;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&#xa0;2 diabetes (T2D).</p> Methods <p>Adults were randomized 1:1 to icodec and once-daily placebo (icodec; <i>n</i> = 72) or degludec and once-weekly placebo (degludec; <i>n</i> = 73). The primary endpoint was change in glycated hemoglobin (HbA<sub>1c</sub>) (baseline to week&#xa0;26). Secondary assessments included change in fasting plasma glucose (FPG; baseline to week&#xa0;26); total weekly insulin dose (weeks&#xa0;24–26); body weight change (baseline to week&#xa0;26); and clinically significant or severe hypoglycemia rates (baseline to week&#xa0;31 [5-week follow-up included]).</p> Results <p>At week&#xa0;26, from baseline values of 8.22% (icodec) and 8.39% (degludec), estimated mean changes in HbA<sub>1c</sub> were − 1.38% points and − 1.10% points, respectively (estimated treatment difference [95% confidence interval], − 0.28%-points [− 0.50%-points, − 0.05%-points]; <i>p</i> = 0.0152). For icodec and degludec, estimated mean FPG change (− 2.3&#xa0;mmol/L vs. − 2.3&#xa0;mmol/L), estimated mean insulin doses (158&#xa0;U/week vs. 142&#xa0;U/week), and estimated body weight change (2.5&#xa0;kg vs. 2.4&#xa0;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.</p> Conclusion <p>In insulin-naive Chinese individuals with T2D, once-weekly icodec treatment showed significantly greater HbA<sub>1c</sub> reductions after 26&#xa0;weeks than once-daily degludec, with low combined clinically significant or severe hypoglycemia rates across groups.</p> ClinicalTrials.gov identifier <p>NCT04795531.</p>

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Once-Weekly Insulin Icodec Versus Once-Daily Insulin Degludec in Insulin-Naive Chinese Participants with Type 2 Diabetes: A Post Hoc Analysis of ONWARDS 3

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  • 发表日期：

    2025年2月28日

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  • Yijun Li,
  • Soumitra Kar,
  • Congcong Li,
  • Ming Liu,
  • Zijian Luan,
  • Guoyue Yuan,
  • Xing Zhong,
  • Yiming Mu

摘要

Introduction

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).

Methods

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 (HbA1c) (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]).

Results

At week 26, from baseline values of 8.22% (icodec) and 8.39% (degludec), estimated mean changes in HbA1c 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.

Conclusion

In insulin-naive Chinese individuals with T2D, once-weekly icodec treatment showed significantly greater HbA1c reductions after 26 weeks than once-daily degludec, with low combined clinically significant or severe hypoglycemia rates across groups.

ClinicalTrials.gov identifier

NCT04795531.