Peking University First Hospital, Beijing, China.
Jinan Central Hospital, Jinan, China.
Diabetes Obes Metab. 2022 Nov;24(11):2182-2191. doi: 10.1111/dom.14803. Epub 2022 Jul 25.
To evaluate the efficacy and safety of iGlarLixi compared with iGlar in Chinese adults with type 2 diabetes advancing therapy from basal insulin ± oral antihyperglycaemic drugs.
LixiLan-L-CN (NCT03798080) was a 30-week randomized, active-controlled, open-label, parallel-group, multicentre study. Participants were randomized 1:1 to iGlarLixi or iGlar. The primary objective was to show the superiority of iGlarLixi over iGlar in glycated haemoglobin (HbA1c) change from baseline to Week 30.
In total, 426 participants were randomized to iGlarLixi (n = 212) or iGlar (n = 214). Mean age was 58 years, 67% had a body mass index ≥24 kg/m , corresponding to overweight/obesity, and the mean diabetes duration was 12.3 years. From mean baseline HbA1c of 8.1% in both groups, greater decreases were seen with iGlarLixi versus iGlar [least squares mean difference: -0.7 (95% confidence interval: -0.9, -0.6)%; p < .0001] to final HbA1c of 6.7% and 7.4%, respectively. HbA1c <7.0% achievement was greater with iGlarLixi (63.3%) versus iGlar (29.9%; p < .0001). Mean body weight decreased with iGlarLixi and increased with iGlar [least squares mean difference: -0.9 (95% confidence interval: -1.4, -0.5) kg; p = .0001]. Hypoglycaemia incidence was similar between groups. Few gastrointestinal adverse events occurred (rated mild/moderate) with a slightly higher incidence with iGlarLixi than iGlar.
iGlarLixi provided better glycaemic control and facilitated more participants to reach glycaemic targets alongside beneficial effects on body weight, no additional risk of hypoglycaemia, and few gastrointestinal AEs, supporting iGlarLixi use as an efficacious and well tolerated therapy option in Chinese people with long-standing T2D advancing therapy from basal insulin.
评估 iGlarLixi 对比 iGlar 在既往接受基础胰岛素联合口服降糖药治疗的中国 2 型糖尿病成人患者中的疗效和安全性。
LixiLan-L-CN（NCT03798080）是一项 30 周、随机、活性对照、开放标签、平行组、多中心研究。参与者按 1:1 随机分配至 iGlarLixi 或 iGlar 组。主要终点为 iGlarLixi 相较于 iGlar 在基线至 30 周时糖化血红蛋白（HbA1c）的变化中展现出优越性。
共 426 名参与者随机分配至 iGlarLixi（n=212）或 iGlar（n=214）组。平均年龄为 58 岁，67%的参与者体重指数（BMI）≥24kg/m²，对应超重/肥胖，平均糖尿病病程为 12.3 年。两组基线时 HbA1c 的平均水平均为 8.1%，与 iGlar 相比，iGlarLixi 组 HbA1c 降幅更大[最小二乘均数差值：-0.7（95%置信区间：-0.9，-0.6）%；p<0.0001]，最终 HbA1c 分别降至 6.7%和 7.4%。iGlarLixi 组（63.3%）HbA1c<7.0%的达标率高于 iGlar 组（29.9%；p<0.0001）。与 iGlar 相比，iGlarLixi 治疗时体重下降（最小二乘均数差值：-0.9kg；95%置信区间：-1.4，-0.5），而 iGlar 治疗时体重增加。两组低血糖发生率相似。胃肠道不良事件（轻/中度）的发生率较低，iGlarLixi 组略高于 iGlar 组。
iGlarLixi 可更好地控制血糖，使更多参与者达到血糖目标，同时对体重有益，低血糖风险无增加，胃肠道不良事件少，支持 iGlarLixi 在中国长期接受基础胰岛素治疗的 2 型糖尿病患者中的有效性和良好耐受性。
