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

被引:0
作者
Li, Yijun [1 ]
Kar, Soumitra [2 ]
Li, Congcong [3 ]
Liu, Ming [4 ]
Luan, Zijian [5 ]
Yuan, Guoyue [6 ]
Zhong, Xing [5 ]
Mu, Yiming [1 ]
机构
[1] Chinese Peoples Liberat Army Gen Hosp, Med Ctr 1, Dept Endocrinol, Beijing 100853, Peoples R China
[2] Novo Nordisk Serv Ctr India Private Ltd, Bangalore, India
[3] Shandong First Med Univ, Cent Hosp, Dept Gen Practice, Jinan, Peoples R China
[4] Tianjin Med Univ, Gen Hosp, Dept Endocrinol & Metab, Tianjin, Peoples R China
[5] Novo Nordisk Pharmaceut Co Ltd, Beijing, Peoples R China
[6] Jiangsu Univ, Affiliated Hosp, Dept Endocrinol, Zhenjiang, Jiangsu, Peoples R China
关键词
Antidiabetic drug; Basal insulin; Insulin analogues; Phase; 3; study; Type; 2; diabetes; OPEN-LABEL; GLYCEMIC CONTROL; RISK-FACTORS; PHASE; 3A; GLARGINE; TRIAL; INDIVIDUALS; PREVALENCE; INITIATION;
D O I
10.1007/s13300-025-01701-2
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
IntroductionThis 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).MethodsAdults 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]).ResultsAt 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.ConclusionIn 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 identifierNCT04795531.
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页码:685 / 699
页数:15
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