Matsuhisa Munehide, Miyoshi Hideaki, Yabe Daisuke, Takahashi Yoko, Morimoto Yukiko, Terauchi Yasuo
Diabetes Therapeutics and Research Center, Institute of Advanced Medical Sciences, Tokushima University, Tokushima, Japan.
Department of Immunology and Metabolism, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.
Diabetes Ther. 2023 Jan;14(1):219-236. doi: 10.1007/s13300-022-01333-w. Epub 2022 Nov 23.
Many individuals with type 2 diabetes (T2D) experience suboptimal glycemic control. Treatment intensification options include fixed-ratio combination products containing a basal insulin and a glucagon-like peptide-1 receptor agonist, such as iGlarLixi (insulin glargine 100 U/mL and lixisenatide). This study aimed to provide real-world evidence of the effect of iGlarLixi in Japanese clinical practice.
SPARTA Japan was a non-comparative, observational study conducted at 27 institutions in Japan. Anonymized individual-level data from adults with T2D receiving iGlarLixi in routine clinical practice were retrospectively collected. The primary study objective was to assess the impact of iGlarLixi on the change in glycated hemoglobin (HbA1c) at 6 months' post-treatment initiation, with preplanned subanalyses to determine the influence of baseline characteristics. Secondary and exploratory endpoints included assessment of the proportion of individuals achieving HbA1c targets, change in body weight, and incidence and severity of hypoglycemia and gastrointestinal events.
The full analysis set included 432 individuals, with data available at 6 months for 426. Of the 432 individuals, the mean (SD) age at baseline was 61.6 (12.8) years and the majority had a T2D duration of ≥ 10 years [mean (SD) 13.3 (10.4) years]. At 6 months, HbA1c had significantly decreased versus baseline ( -0.85%; P < 0.0001), with a greater decrease in those aged < 65 years, with a shorter duration of T2D and higher baseline HbA1c. A significant increase in the proportion of participants achieving age-specific HbA1c versus baseline was observed. Mean body weight decreased by 0.5 kg (P = 0.0034 versus baseline). There were few hypoglycemia and gastrointestinal events (in individuals with HbA1c data); no severe hypoglycemic events were reported.
The results of this real-world study indicate that iGlarLixi may improve glycemic control without serious adverse events in Japanese individuals with T2D who have suboptimal glycemic control on current treatment regimens and switch to iGlarLixi.
UMIN-CTR Trials Registry, UMIN000044126; registered 10 May 2021.
许多2型糖尿病（T2D）患者的血糖控制欠佳。强化治疗方案包括含有基础胰岛素和胰高血糖素样肽-1受体激动剂的固定比例复方制剂，如iGlarLixi（甘精胰岛素100 U/mL和利司那肽）。本研究旨在提供iGlarLixi在日本临床实践中效果的真实世界证据。
日本SPARTA研究是一项在日本27家机构进行的非对照观察性研究。回顾性收集了在常规临床实践中接受iGlarLixi治疗的成年T2D患者的匿名个体水平数据。主要研究目标是评估iGlarLixi对治疗开始后6个月糖化血红蛋白（HbA1c）变化的影响，并进行预先计划的亚组分析以确定基线特征的影响。次要终点和探索性终点包括评估达到HbA1c目标的个体比例、体重变化以及低血糖和胃肠道事件的发生率和严重程度。
完整分析集包括432名个体，其中426名在6个月时有可用数据。在这432名个体中，基线时的平均（标准差）年龄为61.6（12.8）岁，大多数人的T2D病程≥10年[平均（标准差）13.3（10.4）年]。在6个月时，HbA1c较基线时显著降低（-0.85%；P<0.0001），年龄<65岁、T2D病程较短且基线HbA1c较高的患者降低幅度更大。观察到达到特定年龄HbA1c目标的参与者比例相对于基线有显著增加。平均体重下降了0.5 kg（与基线相比，P=0.0034）。低血糖和胃肠道事件较少（有HbA1c数据的个体）；未报告严重低血糖事件。
这项真实世界研究的结果表明，对于目前治疗方案血糖控制欠佳且改用iGlarLixi的日本T2D患者，iGlarLixi可能改善血糖控制且无严重不良事件。
UMIN-CTR试验注册中心，UMIN000044126；2021年5月10日注册。
