Li Wei, Ping Fan, Xu Lingling, Zhang Huabing, Dong Yaxiu, Yu Kang, Li Yuxiu
Department of Endocrinology, Key Laboratory of Endocrinology of National Health Commission, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Department of Clinical Nutrition, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Diabetes Ther. 2020 Mar;11(3):643-654. doi: 10.1007/s13300-020-00766-5. Epub 2020 Jan 24.
To investigate the safety of insulin lispro Mix 25 and 50 (LM25 and LM50) in hypoglycemia in patients with type 2 diabetes mellitus (T2DM).
This was a post hoc analysis of a phase IV, randomized, crossover clinical trial in Chinese patients with T2DM switching from premixed human insulin 70/30 (PHI70/30) to LM25 or LM50. Eighty-one subjects received a two-stage crossover protocol of either LM25 or LM50 twice daily for 16 weeks. Habitual diet was taken, and self-monitoring of blood glucose (SMBG) was performed throughout the study period. High-carbohydrate diet (HCD), high-fat diet (HFD) and habitual diet patterns were taken, and 72 h continuous glucose monitoring (CGM) was performed at the last 3 days of each treatment stage.
The frequencies of nocturnal hypoglycemia in LM50 were lower than those in LM25 under a Chinese habitual diet pattern. The related factors of hypoglycemia in patients with T2DM treated with a LM25 or LM50 regimen were the weight-based daily mean insulin dose and the type of combined oral hypoglycemic agents. Under both HCD and habitual diet patterns, the optimal cut point values of bedtime glucose predicting nocturnal hypoglycemia in LM50 were lower than those in LM25.
The risk of nocturnal hypoglycemia in the LM50 regimen was lower than that in the LM25 regimen under the HCD pattern, and the safety range of bedtime glucose for the LM50 regimen was wider than that of the LM25 regimen in Chinese T2DM patients. Premixed insulin analogs combined with acarbose were more helpful to reduce the incidence of hypoglycemia.
http://www.chictr.org.cn #ChiCTR-TTRCC-12002516.
探讨赖脯胰岛素25/75混合制剂和50/50混合制剂（LM25和LM50）在2型糖尿病（T2DM）患者低血糖发生时的安全性。
这是一项对中国T2DM患者从预混人胰岛素70/30（PHI70/30）转换为LM25或LM50的IV期随机交叉临床试验的事后分析。81名受试者接受了为期16周的两阶段交叉方案，每日两次使用LM25或LM50。维持习惯饮食，并在整个研究期间进行血糖自我监测（SMBG）。采用高碳水化合物饮食（HCD）、高脂肪饮食（HFD）和习惯饮食模式，并在每个治疗阶段的最后3天进行72小时连续血糖监测（CGM）。
在中国人习惯饮食模式下，LM50夜间低血糖的发生率低于LM25。接受LM25或LM50治疗方案的T2DM患者低血糖的相关因素是基于体重的每日平均胰岛素剂量和联合口服降糖药的类型。在HCD和习惯饮食模式下，LM50预测夜间低血糖的睡前血糖最佳切点值均低于LM25。
在HCD模式下，LM50治疗方案夜间低血糖风险低于LM25治疗方案，且在中国T2DM患者中，LM50治疗方案的睡前血糖安全范围比LM25治疗方案更宽。预混胰岛素类似物联合阿卡波糖更有助于降低低血糖发生率。
http://www.chictr.org.cn #ChiCTR-TTRCC-12002516
