IDegAsp 在韩国 2 型糖尿病患者中的有效性和安全性。

IF 6.8 2区 医学 Q1 ENDOCRINOLOGY & METABOLISM
Diabetes & Metabolism Journal Pub Date : 2024-09-01 Epub Date: 2024-02-27 DOI:10.4093/dmj.2023.0297
Shinae Kang, Yu-Bae Ahn, Tae Keun Oh, Won-Young Lee, Sung Wan Chun, Boram Bae, Amine Dahaoui, Jin Sook Jeong, Sungeun Jung, Hak Chul Jang
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引用次数: 0

摘要

研究背景本研究调查了韩国2型糖尿病(T2DM)成人患者改用IDegAsp胰岛素治疗后,德格列奈胰岛素/门冬胰岛素(IDegAsp)的实际疗效和安全性:这是一项多中心、回顾性、观察性研究,包括改用 IDegAsp 前和改用 IDegAsp 后两个为期 26 周的治疗期。研究对象为使用基础胰岛素或预混胰岛素(不含口服抗糖尿病药物)治疗的未得到控制的 T2DM 韩国成人患者。主要目的是比较每个 26 周观察期内糖化血红蛋白(HbA1c)的变化程度。分析包括 HbA1c、空腹血浆葡萄糖 (FPG)、体重的变化,以及达到 HbA1c 结果的参与者比例:共分析了 196 名成人(平均年龄 65.95 岁;T2DM 平均持续时间 18.99 年)。转换前和转换后,HbA1c 和 FPG 的变化均有显著差异(0.28% 对 -0.51%,PC结论:在韩国的实际临床实践中,将胰岛素治疗方案改为IDegAsp与血糖控制的改善相关,而不会增加低血糖的发生,这支持将IDegAsp用于基础胰岛素或预混合胰岛素无法控制的T2DM患者。
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 Safety of IDegAsp in a Real-World Korean Population with Type 2 Diabetes Mellitus.

Backgruound: This study investigated the real-world efficacy and safety of insulin degludec/insulin aspart (IDegAsp) in Korean adults with type 2 diabetes mellitus (T2DM), whose insulin treatment was switched to IDegAsp.

Methods: This was a multicenter, retrospective, observational study comprising two 26-week treatment periods, before and after switching to IDegAsp, respectively. Korean adults with uncontrolled T2DM treated with basal or premix insulin (±oral antidiabetic drugs) were enrolled. The primary objective was to compare the degree of glycosylated hemoglobin (HbA1c) change in each 26-week observation period. The analyses included changes in HbA1c, fasting plasma glucose (FPG), body weight, proportion of participants achieving HbA1c <7.0%, hypoglycemic events, and total daily insulin dose (ClinicalTrials.gov, number NCT04656106).

Results: In total, 196 adults (mean age, 65.95 years; mean T2DM duration, 18.99 years) were analyzed. The change in both HbA1c and FPG were significantly different between the pre-switching and the post-switching period (0.28% vs. -0.51%, P<0.001; 5.21 mg/dL vs. -23.10 mg/dL, P=0.005), respectively. After switching, the rate of achieving HbA1c <7.0% was significantly improved (5.10% at baseline vs. 11.22% with IDegAsp, P=0.012). No significant differences (before vs. after switching) were observed in body weight change, and total daily insulin dose. The rates of overall and severe hypoglycemia were similar in the two periods.

Conclusion: In real-world clinical practice in Korea, the change of insulin regimen to IDegAsp was associated with an improvement in glycemic control without increase of hypoglycemia, supporting the use of IDegAsp for patients with T2DM uncontrolled with basal or premix insulin.

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来源期刊
Diabetes & Metabolism Journal
Diabetes & Metabolism Journal Medicine-Endocrinology, Diabetes and Metabolism
CiteScore
10.40
自引率
6.80%
发文量
92
审稿时长
52 weeks
期刊介绍: The aims of the Diabetes & Metabolism Journal are to contribute to the cure of and education about diabetes mellitus, and the advancement of diabetology through the sharing of scientific information on the latest developments in diabetology among members of the Korean Diabetes Association and other international societies. The Journal publishes articles on basic and clinical studies, focusing on areas such as metabolism, epidemiology, pathogenesis, complications, and treatments relevant to diabetes mellitus. It also publishes articles covering obesity and cardiovascular disease. Articles on translational research and timely issues including ubiquitous care or new technology in the management of diabetes and metabolic disorders are welcome. In addition, genome research, meta-analysis, and randomized controlled studies are welcome for publication. The editorial board invites articles from international research or clinical study groups. Publication is determined by the editors and peer reviewers, who are experts in their specific fields of diabetology.
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