Jochen Seufert MD, Tobias Wiesner MD, Katrin Pegelow PhD, Julia Kenzler PhD, Martin Pfohl MD
{"title":"iGlarLixi在2型糖尿病患者基础胰岛素和口服降糖治疗中的有效性和安全性：一项前瞻性观察性试验","authors":"Jochen Seufert MD, Tobias Wiesner MD, Katrin Pegelow PhD, Julia Kenzler PhD, Martin Pfohl MD","doi":"10.1111/dom.16161","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Aims</h3>\n \n <p>This study assessed efficacy and safety of the fixed ratio combination iGlarLixi 100/33 (insulin glargine 100 U/mL plus lixisenatide 33 μg/mL) in people with type 2 diabetes (PwT2D) in daily clinical practice.</p>\n </section>\n \n <section>\n \n <h3> Materials and Methods</h3>\n \n <p>This non-interventional, multicentre, prospective, single-arm 24-week study documented PwT2D with an HbA1c of 7.5%–10.0%, currently treated with a basal insulin supported oral therapy (BOT) in German primary care facilities, after the physician had decided to change treatment to iGlarLixi 100/33, independent of study participation. Primary end-point was the absolute change in HbA1c (%) from baseline.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>Of 93 participants included, 70 comprised the full analysis set for efficacy assessment. Approximately 24 weeks after switching to iGlarLixi 100/33 HbA1c (mean ± standard deviation) changed from 8.52 ± 0.82% by −0.74 ± 0.81% to 7.74 ± 0.76%, FPG from 174.3 ± 44.6 mg/dL (9.67 ± 2.48 mmol/L) by −32.9 ± 46.3 mg/dL (−1.83 ± 2.57 mmol/L) to 141.4 ± 34.1 mg/dL (7.85 ± 1.89 mmol/L) and body weight from 104.3 ± 22.5 kg by −3.0 ± 7.5 kg to 101.3 ± 21.6 kg (all <i>p</i> < 0.01). Furthermore, use of DPP4 inhibitors was significantly reduced from 34.8% to 6.8% of participants. Derived (from 7-point self-measured plasma glucose) time in range (TIR) increased and time above range (TAR) decreased after 24 weeks to target ranges (all <i>p</i> < 0.05). Flash glucose monitoring data of 20 patients showed similar patterns for TIR and TAR, respectively, and a reduction in time below range (<i>p</i> = 0.007). Hypoglycaemia events did not change significantly and were low in number. No severe hypoglycaemia was reported.</p>\n </section>\n \n <section>\n \n <h3> Conclusions</h3>\n \n <p>Modifying antiglycaemic treatment from a BOT regimen to iGlarLixi 100/33 in suboptimal controlled PwT2D in daily clinical practice improved glycaemic control without increasing hypoglycaemia and with favourable body weight change.</p>\n </section>\n </div>","PeriodicalId":158,"journal":{"name":"Diabetes, Obesity & Metabolism","volume":"27 3","pages":"1526-1535"},"PeriodicalIF":5.7000,"publicationDate":"2025-01-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/dom.16161","citationCount":"0","resultStr":"{\"title\":\"Effectiveness and safety of iGlarLixi in people with type 2 diabetes not at target on basal insulin and oral antidiabetic therapy in a prospective observational trial\",\"authors\":\"Jochen Seufert MD, Tobias Wiesner MD, Katrin Pegelow PhD, Julia Kenzler PhD, Martin Pfohl MD\",\"doi\":\"10.1111/dom.16161\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div>\\n \\n \\n <section>\\n \\n <h3> Aims</h3>\\n \\n <p>This study assessed efficacy and safety of the fixed ratio combination iGlarLixi 100/33 (insulin glargine 100 U/mL plus lixisenatide 33 μg/mL) in people with type 2 diabetes (PwT2D) in daily clinical practice.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Materials and Methods</h3>\\n \\n <p>This non-interventional, multicentre, prospective, single-arm 24-week study documented PwT2D with an HbA1c of 7.5%–10.0%, currently treated with a basal insulin supported oral therapy (BOT) in German primary care facilities, after the physician had decided to change treatment to iGlarLixi 100/33, independent of study participation. Primary end-point was the absolute change in HbA1c (%) from baseline.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Results</h3>\\n \\n <p>Of 93 participants included, 70 comprised the full analysis set for efficacy assessment. Approximately 24 weeks after switching to iGlarLixi 100/33 HbA1c (mean ± standard deviation) changed from 8.52 ± 0.82% by −0.74 ± 0.81% to 7.74 ± 0.76%, FPG from 174.3 ± 44.6 mg/dL (9.67 ± 2.48 mmol/L) by −32.9 ± 46.3 mg/dL (−1.83 ± 2.57 mmol/L) to 141.4 ± 34.1 mg/dL (7.85 ± 1.89 mmol/L) and body weight from 104.3 ± 22.5 kg by −3.0 ± 7.5 kg to 101.3 ± 21.6 kg (all <i>p</i> < 0.01). Furthermore, use of DPP4 inhibitors was significantly reduced from 34.8% to 6.8% of participants. Derived (from 7-point self-measured plasma glucose) time in range (TIR) increased and time above range (TAR) decreased after 24 weeks to target ranges (all <i>p</i> < 0.05). Flash glucose monitoring data of 20 patients showed similar patterns for TIR and TAR, respectively, and a reduction in time below range (<i>p</i> = 0.007). Hypoglycaemia events did not change significantly and were low in number. No severe hypoglycaemia was reported.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Conclusions</h3>\\n \\n <p>Modifying antiglycaemic treatment from a BOT regimen to iGlarLixi 100/33 in suboptimal controlled PwT2D in daily clinical practice improved glycaemic control without increasing hypoglycaemia and with favourable body weight change.</p>\\n </section>\\n </div>\",\"PeriodicalId\":158,\"journal\":{\"name\":\"Diabetes, Obesity & Metabolism\",\"volume\":\"27 3\",\"pages\":\"1526-1535\"},\"PeriodicalIF\":5.7000,\"publicationDate\":\"2025-01-06\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://onlinelibrary.wiley.com/doi/epdf/10.1111/dom.16161\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Diabetes, Obesity & Metabolism\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://dom-pubs.onlinelibrary.wiley.com/doi/10.1111/dom.16161\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"ENDOCRINOLOGY & METABOLISM\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Diabetes, Obesity & Metabolism","FirstCategoryId":"3","ListUrlMain":"https://dom-pubs.onlinelibrary.wiley.com/doi/10.1111/dom.16161","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ENDOCRINOLOGY & METABOLISM","Score":null,"Total":0}
Effectiveness and safety of iGlarLixi in people with type 2 diabetes not at target on basal insulin and oral antidiabetic therapy in a prospective observational trial
Aims
This study assessed efficacy and safety of the fixed ratio combination iGlarLixi 100/33 (insulin glargine 100 U/mL plus lixisenatide 33 μg/mL) in people with type 2 diabetes (PwT2D) in daily clinical practice.
Materials and Methods
This non-interventional, multicentre, prospective, single-arm 24-week study documented PwT2D with an HbA1c of 7.5%–10.0%, currently treated with a basal insulin supported oral therapy (BOT) in German primary care facilities, after the physician had decided to change treatment to iGlarLixi 100/33, independent of study participation. Primary end-point was the absolute change in HbA1c (%) from baseline.
Results
Of 93 participants included, 70 comprised the full analysis set for efficacy assessment. Approximately 24 weeks after switching to iGlarLixi 100/33 HbA1c (mean ± standard deviation) changed from 8.52 ± 0.82% by −0.74 ± 0.81% to 7.74 ± 0.76%, FPG from 174.3 ± 44.6 mg/dL (9.67 ± 2.48 mmol/L) by −32.9 ± 46.3 mg/dL (−1.83 ± 2.57 mmol/L) to 141.4 ± 34.1 mg/dL (7.85 ± 1.89 mmol/L) and body weight from 104.3 ± 22.5 kg by −3.0 ± 7.5 kg to 101.3 ± 21.6 kg (all p < 0.01). Furthermore, use of DPP4 inhibitors was significantly reduced from 34.8% to 6.8% of participants. Derived (from 7-point self-measured plasma glucose) time in range (TIR) increased and time above range (TAR) decreased after 24 weeks to target ranges (all p < 0.05). Flash glucose monitoring data of 20 patients showed similar patterns for TIR and TAR, respectively, and a reduction in time below range (p = 0.007). Hypoglycaemia events did not change significantly and were low in number. No severe hypoglycaemia was reported.
Conclusions
Modifying antiglycaemic treatment from a BOT regimen to iGlarLixi 100/33 in suboptimal controlled PwT2D in daily clinical practice improved glycaemic control without increasing hypoglycaemia and with favourable body weight change.
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.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
