背景:现实世界的SPARTA日本研究证实了甘精胰岛素100U/mL加利西拉来(iGlarLixi)固定比例组合在日本2型糖尿病(T2D)患者中的有效性和安全性。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。
方法:回顾性研究,观察性SPARTA日本研究纳入了启动iGlarLixi的T2D成人。在这个分析中,分别评估初过胰岛素和有胰岛素经验的参与者的数据,以比较糖化血红蛋白(HbA1c),iGlarLixi治疗6个月后,达到(“达到”组)和未达到(“未达到”组)年龄确定的血糖指标之间的体重和安全性结果。未达到的组通过治疗期间其iGlarLixi剂量是否增加来进一步分层。
结果:总计,418名参与者被纳入本分析(138名胰岛素初治和280名胰岛素经历)。在初治胰岛素和有胰岛素经验的参与者中,与未达到组相比,达到组的患者年龄较大,基线HbA1c较低.与未达到的组相比,达到的组显示HbA1c相对于基线显著更大的下降(在未接受胰岛素治疗和有胰岛素治疗的参与者中)和显著更大的体重下降(在未接受胰岛素治疗的参与者中),尽管未达到组的一些参与者接受的甘精胰岛素剂量明显高于达到组。在初过胰岛素和有胰岛素经验的参与者中,在已实现和未实现的组中,低血糖和胃肠道相关不良事件的发生率相似.在多变量分析中,在年龄较大的个体和在iGlarLixi治疗期间体重减轻的个体中,实现血糖目标的可能性明显更高。
结论:使用iGlarLixi治疗6个月来实现年龄定义的血糖指标受到年龄增长和体重减轻的显著影响,无论以前的胰岛素暴露。
背景:UMIN-CTR试验注册表,UMIN000044126;2021年5月10日注册。
iGlarLixi是一种用于治疗2型糖尿病的可注射产品,其中包含两种药物的固定组合,甘精胰岛素(浓度为100U/mL)和利西拉来。SPARTA日本研究调查了控制血糖水平的有效性和iGlarLixi在日本人每天服用一次超过6个月作为常规医疗护理的一部分的安全性。本文报道的分析回顾了日本SPARTA的数据,以评估参与研究的人的某些特征是否影响血糖目标的实现程度。以前服用过胰岛素的人和那些没有被确认的人,和他们的结果分别评估。这些人被分为那些已经达到他们的血糖水平目标(目标定义为每个人的糖化血红蛋白水平基于他们的年龄)和那些没有达到他们的目标。结果发现,在接受iGlarLixi的同时达到血糖目标的人年龄更大,在开始iGlarLixi之前有较低的糖化血红蛋白水平,在治疗期间比那些没有达到目标的人体重减轻,无论他们以前是否接受过胰岛素治疗。使用iGlarLixi治疗的过低血糖水平或胃肠道不适的副作用发生在达到或未达到血糖目标的相似数量的人中。
BACKGROUND: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
BACKGROUND: UMIN-CTR Trials Registry, UMIN000044126; registered 10 May 2021.
iGlarLixi is an injectable product used to treat type 2 diabetes that contains a fixed combination of two drugs, insulin glargine (at a concentration of 100 U/mL) and lixisenatide. The SPARTA Japan study investigated the effectiveness of controlling blood glucose levels and the safety of iGlarLixi in Japanese people when taken once daily for over 6 months as part of their routine medical care. The analysis reported in this article looked back at data from SPARTA Japan to assess whether certain characteristics of the people who took part in the study affected how well blood glucose targets were met. People who had previously taken insulin and those who had not were identified, and their results were assessed separately. The people were divided into those who had met their blood glucose level target (with the target defined as the glycated haemoglobin level for each person based on their age) and those who had not met their target. It was found that people who achieved their blood glucose target while receiving
iGlarLixi were more likely to be older, to have had a lower glycated haemoglobin level before starting iGlarLixi, and to have lost weight during treatment than those who did not achieve their target, whether or not they had previously been treated with insulin. Side effects of excessively low blood glucose levels or gastrointestinal upset with iGlarLixi treatment occurred in a similar number of people who achieved or did not achieve their blood glucose target.