AimTo assess the impact of insulin glargine (100 U/mL) and lixisenatide (iGlarLixi) fixed‐ratio combination therapy on the overall management of glycaemia in patients with type 2 diabetes (T2D), previously inadequately controlled with oral antidiabetic drugs ± basal insulin or glucagon‐like peptide‐1 receptor agonists (GLP‐1 RAs).Materials and MethodsThis 12‐month, international, multicentre, prospective, observational study included patients (age ≥ 18 years) with T2D who had initiated iGlarLixi within 1 month prior to study inclusion. Data were collected at study inclusion, month 3, month 6 and month 12 from patient diaries, self‐measured plasma glucose, and questionnaires. The primary endpoint was change in HbA1c from baseline to month 6.ResultsOf the 737 eligible participants (mean age: 57.8 [standard deviation: 11.2] years; male: 49%), 685 had baseline and post‐baseline HbA1c data available. The least squares mean change in HbA1c from baseline to month 6 was −1.4% (standard error [95% confidence interval (CI)]: 0.05 [−1.5, −1.3]). The absolute change from baseline at month 12 was −1.7% ± 1.9% (95% CI: −1.9, −1.5). There were 72 hypoglycaemia events reported during the study period, with a very low incidence of severe hypoglycaemia (two participants [rate: 0.003 events per patient‐year]).ConclusionsThis real‐world observational study shows that initiation of iGlarLixi in people with T2D inadequately controlled on oral antidiabetic drugs ± basal insulin or GLP‐1 RAs improves glycaemic control with a low incidence of hypoglycaemia.

中文翻译：

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甘精胰岛素 100 U/mL 加利西拉来治疗成人 2 型糖尿病的真实有效性和安全性：一项国际、多中心、12 个月的前瞻性观察研究

目的 评估甘精胰岛素 (100 U/mL) 和利司那肽 (iGlarLixi) 固定比例联合治疗对 2 型糖尿病 (T2D) 患者血糖总体管理的影响，此前口服降糖药 ± 基础胰岛素或胰高血糖素样肽-1 受体激动剂 (GLP-1 RA)。 材料和方法这项为期 12 个月的国际多中心前瞻性观察性研究纳入了在研究前 1 个月内开始 iGlarLixi 的 T2D 患者（年龄≥18 岁）包容性。在研究纳入时、第 3 个月、第 6 个月和第 12 个月，通过患者日记、自测血糖和问卷收集数据。主要终点是 HbA1c 从基线到第 6 个月的变化。结果 在 737 名合格参与者中（平均年龄：57.8 [标准差：11.2] 岁；男性：49%），685 名拥有基线和基线后 HbA1c 数据。 HbA1c 从基线到第 6 个月的最小二乘平均变化为 −1.4%（标准误差 [95% 置信区间 (CI)]：0.05 [−1.5，−1.3]）。第 12 个月时相对于基线的绝对变化为 -1.7% ± 1.9% (95% CI: -1.9, -1.5)。研究期间共报告了 72 起低血糖事件，其中严重低血糖的发生率非常低（两名受试者[比率：每名患者年发生 0.003 起事件]）。结论这项真实世界的观察性研究表明，2 型糖尿病患者开始 iGlarLixi 治疗的效果不充分口服抗糖尿病药物±基础胰岛素或GLP-1 RAs可改善血糖控制，低血糖发生率较低。