根据基线胰高血糖素样肽-1受体激动剂和钠-葡萄糖共转运蛋白-2抑制剂的使用,每周一次胰岛素icodec与每日一次基础胰岛素治疗2型糖尿病的疗效和低血糖结局:一项对1-5的事后分析

IF 5.7 2区 医学 Q1 ENDOCRINOLOGY & METABOLISM
Tina Vilsbøll MD, Ariel Fu MD, Monika Kellerer MD, Bharath Kumar MSc, Stinne Byrholdt Søgaard MD, Ronald Goldenberg MD
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引用次数: 0

摘要

目的:根据基线胰高血糖素样肽-1受体激动剂(GLP-1RA)和钠-葡萄糖共转运蛋白-2抑制剂(SGLT2i)的使用情况,评估每周一次胰岛素icodec (icodec)与每日一次基础胰岛素比较剂在2型糖尿病(T2D)患者中的治疗效果。材料和方法:对t2dm患者随机进行的1-5项试验进行事后分析,根据基线GLP-1RA和/或SGLT2i的使用情况,通过试验评估治疗结果。结果:在筛选时,21.3%(801/3765)和36.9%(1388/3765)的参与者分别接受GLP-1RA或SGLT2i治疗。不论是否使用GLP-1RA/SGLT2i,各治疗组的基线特征大致相似;GLP-1RA使用者的身体质量指数高于非使用者。在所有试验中,GLP-1RA或SGLT2i亚组在以下方面的治疗相互作用没有统计学意义:糖化血红蛋白(HbA1c)和体重从基线到治疗结束的变化(除了在第5期使用SGLT2i引起的体重变化);在治疗的最后2周内,每周基础胰岛素剂量(SGLT2i在第5期的使用除外);实现HbA1c低于7%,无临床显著或严重低血糖。无论GLP-1RA/SGLT2i的使用情况如何,在所有试验中,除了基础-大剂量试验(basis -bolus试验),临床显著性或严重低血糖的发生率均小于每患者年1次。结论:与每日一次的对照药相比,icodec的疗效和低血糖状况在所有研究中基本一致,而与GLP-1RA和/或SGLT2i的使用背景无关。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Efficacy and hypoglycaemia outcomes with once-weekly insulin icodec versus once-daily basal insulin in type 2 diabetes according to baseline glucagon-like peptide-1 receptor agonist and sodium-glucose co-transporter-2 inhibitor use: A post hoc analysis of ONWARDS 1–5

Efficacy and hypoglycaemia outcomes with once-weekly insulin icodec versus once-daily basal insulin in type 2 diabetes according to baseline glucagon-like peptide-1 receptor agonist and sodium-glucose co-transporter-2 inhibitor use: A post hoc analysis of ONWARDS 1–5

Efficacy and hypoglycaemia outcomes with once-weekly insulin icodec versus once-daily basal insulin in type 2 diabetes according to baseline glucagon-like peptide-1 receptor agonist and sodium-glucose co-transporter-2 inhibitor use: A post hoc analysis of ONWARDS 1–5

Efficacy and hypoglycaemia outcomes with once-weekly insulin icodec versus once-daily basal insulin in type 2 diabetes according to baseline glucagon-like peptide-1 receptor agonist and sodium-glucose co-transporter-2 inhibitor use: A post hoc analysis of ONWARDS 1–5

Efficacy and hypoglycaemia outcomes with once-weekly insulin icodec versus once-daily basal insulin in type 2 diabetes according to baseline glucagon-like peptide-1 receptor agonist and sodium-glucose co-transporter-2 inhibitor use: A post hoc analysis of ONWARDS 1–5

Aims

To assess the treatment effects of once-weekly insulin icodec (icodec) versus once-daily basal insulin comparators in individuals with type 2 diabetes (T2D) according to baseline glucagon-like peptide-1 receptor agonist (GLP-1RA) and sodium-glucose co-transporter-2 inhibitor (SGLT2i) use.

Materials and Methods

This post hoc analysis of the randomized ONWARDS 1–5 trials of individuals with T2D assessed treatment outcomes by trial according to baseline GLP-1RA and/or SGLT2i use.

Results

At screening, 21.3% (801/3765) and 36.9% (1388/3765) of participants in ONWARDS 1–5 were treated with a GLP-1RA or an SGLT2i, respectively. Baseline characteristics were broadly similar across treatment arms irrespective of GLP-1RA/SGLT2i use; GLP-1RA users had numerically higher body mass indices than non-users. Across trials, there were no statistically significant treatment interactions by GLP-1RA or SGLT2i subgroups with respect to: change in glycated haemoglobin (HbA1c) and body weight from baseline to end of treatment (except for body weight change by SGLT2i use in ONWARDS 5); weekly basal insulin dose during the last 2 weeks of treatment (except SGLT2i use in ONWARDS 5); and achievement of HbA1c less than 7% without clinically significant or severe hypoglycaemia. Irrespective of GLP-1RA/SGLT2i use, the rates of clinically significant or severe hypoglycaemia were less than one episode per patient-year of exposure across all trials except ONWARDS 4 (basal-bolus trial).

Conclusions

The efficacy and hypoglycaemia profile of icodec versus once-daily comparators was generally consistent across ONWARDS trials irrespective of background GLP-1RA and/or SGLT2i use.

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来源期刊
Diabetes, Obesity & Metabolism
Diabetes, Obesity & Metabolism 医学-内分泌学与代谢
CiteScore
10.90
自引率
6.90%
发文量
319
审稿时长
3-8 weeks
期刊介绍: Diabetes, Obesity and Metabolism is primarily a journal of clinical and experimental pharmacology and therapeutics covering the interrelated areas of diabetes, obesity and metabolism. The journal prioritises high-quality original research that reports on the effects of new or existing therapies, including dietary, exercise and lifestyle (non-pharmacological) interventions, in any aspect of metabolic and endocrine disease, either in humans or animal and cellular systems. ‘Metabolism’ may relate to lipids, bone and drug metabolism, or broader aspects of endocrine dysfunction. Preclinical pharmacology, pharmacokinetic studies, meta-analyses and those addressing drug safety and tolerability are also highly suitable for publication in this journal. Original research may be published as a main paper or as a research letter.
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