一项事后汇总分析，旨在评估格列美脲胰岛素 300 U/mL对胰岛素无效的 2 型糖尿病患者的疗效和安全性，这些患者既往接受过胰高血糖素样肽-1 受体激动剂治疗，也未接受过胰高血糖素样肽-1 受体激动剂治疗。

IF 6.1 3区医学 Q1 ENDOCRINOLOGY & METABOLISM

Diabetes research and clinical practice Pub Date : 2024-09-27 DOI:10.1016/j.diabres.2024.111871

Alice Y.Y. Cheng , Didac Mauricio , Robert Ritzel , Mohammed E. Al-Sofiani , Timothy Bailey , Maria Aileen Mabunay , Mireille Bonnemaire , Lydie Melas-Melt , Safia Mimouni , Melanie Davies

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引用次数: 0

摘要

目的：评估 2 型糖尿病（T2D）患者在接受或未接受胰高血糖素样肽-1 受体激动剂（GLP-1 RA）治疗的情况下使用胰岛素格列卫 300 U/mL（Gla-300）的治疗进展：方法：在三项分析（N = 3562）中评估了胰岛素无效患者接受 Gla-300 强化治疗后的疗效和安全性结果（无论之前是否接受过 GLP-1 RA 治疗）：对七项干预性研究的汇总分析、对停止 GLP-1 RA 治疗并开始使用 Gla-300 的患者与接受 Gla-300 附加治疗的患者进行比较的子分析，以及包括两项观察性研究在内的扩展分析：结果：血糖结果（包括 HbA1c 改善和空腹血浆葡萄糖）在使用/未使用 GLP-1 RA 的组别之间相似。使用和未使用过 GLP-1 RA 的 HbA1c 最小二乘法平均值与基线相比的变化分别为 - 1.7 % 和 - 1.6 %。在开始使用 Gla-300 时停止 GLP-1 RA 治疗的参与者与接受附加 Gla-300 治疗的参与者的血糖结果相似，但更多接受附加 Gla-300 治疗的参与者达到了 HbA1c 目标。扩大分析得出了类似的结果。在所有分析中，低血糖发生率较低，体重没有发生临床相关变化：结论：对既往接受过/未接受过 GLP-1 RA 治疗的 T2D 患者使用 Gla-300 提前治疗可改善血糖结果，对体重无相关影响，同时低血糖风险较低。

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A post-hoc pooled analysis to evaluate efficacy and safety of insulin glargine 300 U/mL in insulin-naïve people with type 2 diabetes with/without prior use of glucagon-like peptide-1 receptor agonist therapy

Aims

To evaluate treatment advancement with insulin glargine 300 U/mL (Gla-300), with or without prior glucagon-like peptide-1 receptor agonist (GLP-1 RA) therapy in type 2 diabetes (T2D).

Methods

Efficacy and safety outcomes of insulin-naïve patients intensifying with Gla-300, with/without prior GLP-1 RA therapy, were evaluated in three analyses (N = 3562): a pooled analysis of seven interventional studies, a subanalysis comparing participants who stopped GLP-1 RA therapy and initiated Gla-300 with those who received add-on Gla-300, and an expanded analysis including two observational studies.

Results

Glycaemic outcomes, including HbA1c improvement and fasting plasma glucose, were similar between groups with/without prior GLP-1 RA use. HbA1c least squares mean change from baseline was − 1.7 % and − 1.6 % with and without prior GLP-1 RA, respectively. Glycaemic outcomes were similar between participants who stopped GLP-1 RA therapy when initiating Gla-300 and those who received add-on Gla-300, although more participants receiving add-on Gla-300 achieved HbA1c targets. The expanded analysis yielded similar results. Incidence of hypoglycaemia was low with no clinically relevant weight changes in all analyses.

Conclusions

Treatment advancement with Gla-300 in patients with T2D, with/without prior GLP-1 RA therapy, improved glycaemic outcomes with no relevant impact on weight, while maintaining a low hypoglycaemia risk.

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来源期刊

Diabetes research and clinical practice 医学-内分泌学与代谢

CiteScore

10.30

自引率

3.90%

发文量

862

审稿时长

32 days

期刊介绍： Diabetes Research and Clinical Practice is an international journal for health-care providers and clinically oriented researchers that publishes high-quality original research articles and expert reviews in diabetes and related areas. The role of the journal is to provide a venue for dissemination of knowledge and discussion of topics related to diabetes clinical research and patient care. Topics of focus include translational science, genetics, immunology, nutrition, psychosocial research, epidemiology, prevention, socio-economic research, complications, new treatments, technologies and therapy.