Quality of Life in Japanese People with Type 2 Diabetes Switching from Multiple Daily Insulin Injections to Once-Daily iGlarLixi: SIMPLIFY Japan.

IF 3.8 3区医学 Q2 Medicine

Diabetes Therapy Pub Date : 2024-11-01 Epub Date: 2024-09-30 DOI:10.1007/s13300-024-01645-z

Hitoshi Ishii, Hideki Kamiya, Yoko Takahashi, Yukiko Morimoto, Daisuke Yabe

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Abstract

Introduction: Previous studies have shown that iGlarLixi, a fixed-ratio combination of insulin glargine 100 U/ml and lixisenatide, provides effective glycemic control in people with type 2 diabetes (T2D). The SIMPLIFY Japan study assessed the impact of switching from multiple daily insulin injections (MDI) to once-daily iGlarLixi on health-related quality of life (HRQOL) and glycemic parameters in Japanese people with moderately controlled T2D.

Methods: This 24-week, prospective, observational cohort study enrolled Japanese adults with T2D who switched from MDI therapy to iGlarLixi. Data were collected at baseline, 12, and 24 weeks; changes in Diabetes Therapy-Related Quality of Life (DTR-QOL) questionnaire score, glycated hemoglobin (HbA1c), body weight and self-reported treatment adherence were evaluated; the primary endpoint was change in DTR-QOL at 24 weeks.

Results: Sixty-six participants were enrolled and 61 were included in the full analysis set. Significant improvements were observed in total DTR-QOL score from baseline to week 24 (mean change + 10.8 points; P < 0.001), with higher scores observed in individual domains related to social/daily activities, treatment satisfaction, and reductions in treatment-related anxiety (P < 0.05). A small HbA1c increase was noted at week 24 (P < 0.001), while this did not appear to adversely affect HRQOL or treatment satisfaction. A significant reduction in body weight was observed at week 12 (mean change - 0.7 kg; P = 0.046). Self-reported treatment adherence increased from baseline to week 24, with the proportion of participants who never missed an insulin injection increasing from 55.7 to 77.6%. At week 24, the incidence of hypoglycemia and gastrointestinal adverse events was 18.2 and 27.3%, respectively.

Conclusions: Switching from MDI to iGlarLixi therapy in Japanese people with T2D was associated with enhanced HRQOL (despite slight elevation in HbA1c) and improved treatment adherence, with a favorable safety profile. These findings support the beneficial role of iGlarLixi in the management of T2D in real-world Japanese clinical practice.

Study registration: Japan Registry of Clinical Trials (jRCT1041210151).

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日本 2 型糖尿病患者从每天多次注射胰岛素转为每天注射一次 iGlarLixi 后的生活质量：日本 SIMPLIFY。

简介先前的研究表明，iGlarLixi（一种由格列奈胰岛素 100 U/ml 和利塞那肽组成的固定比例复方制剂）可有效控制 2 型糖尿病（T2D）患者的血糖。日本 SIMPLIFY 研究评估了从每日多次胰岛素注射 (MDI) 改为每日一次 iGlarLixi 对健康相关生活质量 (HRQOL) 和血糖参数的影响：这项为期 24 周的前瞻性观察性队列研究招募了从 MDI 治疗转为 iGlarLixi 治疗的日本成人 T2D 患者。在基线、12周和24周收集数据；评估糖尿病治疗相关生活质量（DTR-QOL）问卷评分、糖化血红蛋白（HbA1c）、体重和自我报告的治疗依从性的变化；主要终点是24周时DTR-QOL的变化：结果：共有 66 人参加了研究，其中 61 人被纳入完整的分析集。从基线到第 24 周，DTR-QOL 总分有明显改善（平均变化 + 10.8 分；P 结论：从 MDI 转为 iGG，DTR-QOL 总分有明显改善：日本 T2D 患者从 MDI 转为 iGlarLixi 治疗与 HRQOL 的提高（尽管 HbA1c 略有升高）和治疗依从性的改善有关，同时具有良好的安全性。这些研究结果支持iGlarLixi在日本临床实践中治疗T2D的有益作用：研究注册：日本临床试验注册中心（jRCT1041210151）。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Diabetes Therapy Medicine-Endocrinology, Diabetes and Metabolism

CiteScore

6.90

自引率

7.90%

发文量

130

审稿时长

6 weeks

期刊介绍： Diabetes Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all areas of diabetes. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Diabetes Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.