Yabe Daisuke, Matsuhisa Munehide, Takahashi Yoko, Morimoto Yukiko, Terauchi Yasuo
Department of Diabetes, Endocrinology and Metabolism, and Department of Rheumatology and Clinical Immunology, Gifu University Graduate School of Medicine, Gifu, Japan.
Center for One Medicine Innovative Translational Research, Gifu University, Gifu, Japan.
Diabetes Ther. 2024 Mar;15(3):705-723. doi: 10.1007/s13300-024-01531-8. Epub 2024 Feb 16.
The real-world SPARTA Japan study confirmed the effectiveness and safety of the fixed-ratio combination of insulin glargine 100 U/mL plus lixisenatide (iGlarLixi) once daily over 6 months in Japanese people with type 2 diabetes (T2D). This post hoc analysis examined the impact of participant characteristics on the achievement of age-defined glycaemic targets with iGlarLixi therapy.
The retrospective, observational SPARTA Japan study included adults with T2D who initiated iGlarLixi. In this analysis, data from insulin-naïve and insulin-experienced participants were separately assessed to compare glycated haemoglobin (HbA1c), body weight and safety outcomes between those who achieved ('achieved' group) and those who did not achieve ('not-achieved' group) age-defined glycaemic targets after 6 months of iGlarLixi. The not-achieved group was further stratified by whether or not their iGlarLixi dose was increased during treatment.
In total, 418 participants were included in this analysis (138 insulin naïve and 280 insulin experienced). Among both insulin-naïve and insulin-experienced participants, those in the achieved group were older and had lower baseline HbA1c than those in the not-achieved group. Compared with the not-achieved group, the achieved group showed significantly greater HbA1c reductions from baseline (in both insulin-naïve and insulin-experienced participants) and significantly greater body weight reductions (in insulin-naïve participants), despite some participants in the not-achieved group receiving significantly higher insulin glargine doses than those in the achieved group. In both insulin-naïve and insulin-experienced participants, the incidence of hypoglycaemia and gastrointestinal-related adverse events was similar in the achieved and not-achieved groups. In a multivariate analysis, glycaemic target achievement was significantly more likely in older individuals and those who lost weight during iGlarLixi treatment.
Achievement of age-defined glycaemic targets with iGlarLixi treatment for 6 months was significantly affected by increased age and body weight loss, regardless of prior insulin exposure.
UMIN-CTR Trials Registry, UMIN000044126; registered 10 May 2021.
现实世界中的日本斯巴达研究证实，对于日本2型糖尿病（T2D）患者，甘精胰岛素100 U/mL与利司那肽（iGlarLixi）的固定比例复方制剂每日一次，治疗6个月具有有效性和安全性。这项事后分析研究了参与者特征对iGlarLixi治疗实现年龄定义的血糖目标的影响。
回顾性观察性日本斯巴达研究纳入了开始使用iGlarLixi的T2D成人患者。在该分析中，分别评估了既往未使用胰岛素和曾使用胰岛素的参与者的数据，以比较在iGlarLixi治疗6个月后达到（“达到目标”组）和未达到（“未达到目标”组）年龄定义血糖目标的参与者之间的糖化血红蛋白（HbA1c）、体重和安全性结果。未达到目标组根据其iGlarLixi剂量在治疗期间是否增加进一步分层。
本分析共纳入418名参与者（138名既往未使用胰岛素，280名曾使用胰岛素）。在既往未使用胰岛素和曾使用胰岛素的参与者中，达到目标组的年龄均大于未达到目标组，且基线HbA1c水平低于未达到目标组。与未达到目标组相比，达到目标组的HbA1c较基线水平显著降低（既往未使用胰岛素和曾使用胰岛素的参与者均如此），体重显著下降（既往未使用胰岛素的参与者），尽管未达到目标组的一些参与者接受的甘精胰岛素剂量显著高于达到目标组。在既往未使用胰岛素和曾使用胰岛素的参与者中，达到目标组和未达到目标组的低血糖和胃肠道相关不良事件发生率相似。在多变量分析中，年龄较大的个体以及在iGlarLixi治疗期间体重减轻的个体更有可能实现血糖目标。
无论之前是否使用过胰岛素，iGlarLixi治疗6个月实现年龄定义的血糖目标受年龄增长和体重减轻的显著影响。
UMIN-CTR试验注册库，UMIN000044126；2021年5月10日注册。
