Ishii Hitoshi, Kamiya Hideki, Takahashi Yoko, Morimoto Yukiko, Yabe Daisuke
Department of Doctor-Patient Relationships, Nara Medical University, Nara, Japan.
Division of Diabetes, Department of Internal Medicine, Aichi Medical University School of Medicine, Aichi, Japan.
Diabetes Ther. 2024 Nov;15(11):2381-2400. doi: 10.1007/s13300-024-01645-z. Epub 2024 Sep 30.
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.
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.
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.
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.
Japan Registry of Clinical Trials (jRCT1041210151).
既往研究表明，甘精胰岛素100 U/ml与利司那肽的固定比例复方制剂iGlarLixi可有效控制2型糖尿病（T2D）患者的血糖。SIMPLIFY日本研究评估了日本中度控制的T2D患者从每日多次胰岛素注射（MDI）转换为每日一次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纳入了从MDI治疗转换为iGlarLixi的日本成年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变化；主要终点是24周时DTR-QOL的变化。
共纳入66名参与者，61名被纳入全分析集。从基线到24周，DTR-QOL总分有显著改善（平均变化+10.8分；P<0.001），在与社交/日常活动、治疗满意度相关的各个领域得分更高，且治疗相关焦虑有所降低（P<0.05）。24周时HbA1c略有升高（P<0.001），但这似乎并未对HRQOL或治疗满意度产生不利影响。12周时体重显著下降（平均变化-0.7 kg；P=0.046）。自我报告的治疗依从性从基线到24周有所提高，从未错过胰岛素注射的参与者比例从55.7%增加到77.6%。24周时，低血糖和胃肠道不良事件的发生率分别为18.2%和27.3%。
在日本T2D患者中，从MDI转换为iGlarLixi治疗可提高HRQOL（尽管HbA1c略有升高）并改善治疗依从性，且安全性良好。这些发现支持了iGlarLixi在日本现实临床实践中管理T2D的有益作用。
日本临床试验注册中心（jRCT1041210151）
