Department of Endocrinology, Ochsner Medical Center, New Orleans, LA, USA.
AMCR Institute, Inc., Escondido, CA, USA.
Adv Ther. 2019 Sep;36(9):2310-2326. doi: 10.1007/s12325-019-01033-1. Epub 2019 Jul 29.
iGlarLixi is a titratable, fixed-ratio combination of insulin glargine (iGlar, 100 units/ml) and the glucagon-like peptide-1 receptor agonist lixisenatide for the treatment of patients with type 2 diabetes. This post hoc analysis of the phase 3 LixiLan-L trial (NCT02058160) investigated baseline characteristics, glycemic control, and safety outcomes in participants who received the study-specified maximum dose (60 units/day) of iGlarLixi or iGlar vs. those who received < 60 units/day.
Outcomes were compared for participants receiving 60 or < 60 units/day at week 30. Endpoints analyzed included change in A1C, fasting plasma glucose (FPG), 2-h postprandial glucose (2-h PPG), body weight, proportion of participants achieving A1C < 7.0%, proportion of participants receiving rescue therapy, documented symptomatic hypoglycemia, and gastrointestinal adverse event (GI AE) incidence.
By week 30, 27% (iGlarLixi) and 31% (iGlar) of participants received the maximum dose. Participants on 60 vs. < 60 units/day were younger and had higher body weight, body mass index (BMI), FPG, and baseline insulin dose. In both dose groups, A1C change from baseline was significantly greater with iGlarLixi vs. iGlar, and more participants treated with iGlarLixi vs. iGlar achieved A1C < 7.0%. No significant differences were observed in change from baseline for A1C, FPG, 2-h PPG, or GI AE incidence between insulin dose groups, regardless of treatment. In both treatment arms, incidence of symptomatic hypoglycemia was lower in participants receiving 60 units/day vs. those receiving < 60 units/day. Participants treated with iGlarLixi (< 60 or 60 units/day) had modest weight loss over 30 weeks vs. an increase in weight compared with iGlar.
Maximum doses of iGlarLixi were required in participants with a more insulin-resistant clinical phenotype (younger, higher BMI, FPG, and insulin doses). Benefits were observed with iGlarLixi vs. iGlar, even at 60 units/day, with more participants achieving glycemic goals, no increase in symptomatic hypoglycemia, and a modest reduction in body weight.
Sanofi US, Inc.
iGlarLixi 是一种可滴定的、固定比例的胰岛素 glargine（iGlar，100 单位/毫升）和胰高血糖素样肽-1 受体激动剂 lixisenatide 的组合，用于治疗 2 型糖尿病患者。这项 3 期 LixiLan-L 试验（NCT02058160）的事后分析调查了接受研究规定的 iGlarLixi 最大剂量（60 单位/天）或 iGlar 治疗的参与者的基线特征、血糖控制和安全性结局，以及接受<60 单位/天的参与者。
在第 30 周时比较接受 60 或<60 单位/天的参与者的结果。分析的终点包括 A1C、空腹血糖（FPG）、餐后 2 小时血糖（2-h PPG）、体重的变化，达到 A1C<7.0%的参与者比例，接受救援治疗的参与者比例，记录的症状性低血糖和胃肠道不良事件（GI AE）的发生率。
在第 30 周时，27%（iGlarLixi）和 31%（iGlar）的参与者接受了最大剂量。与接受<60 单位/天的参与者相比，接受 60 单位/天的参与者年龄更小，体重更高，体重指数（BMI）、FPG 和基线胰岛素剂量更高。在两个剂量组中，与 iGlar 相比，iGlarLixi 治疗后 A1C 从基线的变化显著更大，并且接受 iGlarLixi 治疗的参与者比接受 iGlar 治疗的参与者达到 A1C<7.0%的比例更高。无论治疗如何，从基线到 A1C、FPG、2-h PPG 或 GI AE 发生率的变化，胰岛素剂量组之间均无显著差异。在两个治疗组中，与接受<60 单位/天的参与者相比，接受 60 单位/天的参与者发生症状性低血糖的发生率较低。与 iGlar 相比，接受 iGlarLixi 治疗的参与者（无论接受<60 或 60 单位/天）在 30 周内体重略有下降。
在具有更高胰岛素抵抗临床表型的参与者中（更年轻、更高 BMI、FPG 和胰岛素剂量）需要最大剂量的 iGlarLixi。与 iGlar 相比，即使使用 60 单位/天，iGlarLixi 也显示出益处，更多的参与者达到血糖目标，症状性低血糖没有增加，体重适度减轻。
赛诺菲美国公司。
