Tina Vilsbøll MD, Ariel Fu MD, Monika Kellerer MD, Bharath Kumar MSc, Stinne Byrholdt Søgaard MD, Ronald Goldenberg MD
{"title":"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","authors":"Tina Vilsbøll MD, Ariel Fu MD, Monika Kellerer MD, Bharath Kumar MSc, Stinne Byrholdt Søgaard MD, Ronald Goldenberg MD","doi":"10.1111/dom.16328","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Aims</h3>\n \n <p>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.</p>\n </section>\n \n <section>\n \n <h3> Materials and Methods</h3>\n \n <p>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.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>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).</p>\n </section>\n \n <section>\n \n <h3> Conclusions</h3>\n \n <p>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.</p>\n </section>\n </div>","PeriodicalId":158,"journal":{"name":"Diabetes, Obesity & Metabolism","volume":"27 6","pages":"3165-3175"},"PeriodicalIF":5.7000,"publicationDate":"2025-03-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/dom.16328","citationCount":"0","resultStr":"{\"title\":\"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\",\"authors\":\"Tina Vilsbøll MD, Ariel Fu MD, Monika Kellerer MD, Bharath Kumar MSc, Stinne Byrholdt Søgaard MD, Ronald Goldenberg MD\",\"doi\":\"10.1111/dom.16328\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div>\\n \\n \\n <section>\\n \\n <h3> Aims</h3>\\n \\n <p>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.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Materials and Methods</h3>\\n \\n <p>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.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Results</h3>\\n \\n <p>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. 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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.
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.