Leohr Jennifer, Dellva Mary Anne, LaBell Elizabeth, Coutant David E, Arrubla Jorge, Plum-Mörschel Leona, Zijlstra Eric, Fukuda Tsuyoshi, Hardy Thomas
Eli Lilly and Company, Indianapolis, IN, USA.
Profil, Neuss, Germany.
Diabetes Obes Metab. 2024 Jan;26(1):215-223. doi: 10.1111/dom.15307. Epub 2023 Oct 9.
To compare the time to hyperglycaemia recovery after ultra rapid lispro (URLi; Lyumjev®) versus Humalog in a randomized, double-blind crossover study.
Thirty-two adults with type 1 diabetes on continuous subcutaneous insulin infusion participated in two periods: each period included hyperglycaemia induced by a missed mealtime bolus (day 1) and by suspension of basal insulin delivery (day 2). When hyperglycaemia [plasma glucose (PG) >240 mg/dl] occurred, a correction bolus of URLi or Humalog was given and time to hyperglycaemia recovery (PG = 140 mg/dl), pharmacokinetics and glucodynamics were compared.
Following a missed mealtime bolus, URLi significantly reduced maximum PG (-13 mg/dl; p = .02), and produced numerically more rapid decline in PG (23 mg/dl/h; p = .07), and faster recovery from hyperglycaemia (-23 min; p = .1) versus Humalog, although differences were not significant. Following basal suspension, URLi significantly reduced maximum PG (-6 mg/dl; p = .02), and produced faster PG decline (24 mg/dl/h; p < .001) and faster recovery from hyperglycaemia (-16 min; p < .01) vs. Humalog. Following a correction bolus of URLi, accelerated insulin lispro absorption was observed versus Humalog: early 50% t was reduced by 6 or 12 min, and AUC0-15min was increased 2.5- or 4.3-fold after correction boluses by subcutaneous infusion (day 1) or injection (day 2), respectively (all p < .001).
During episodes of hyperglycaemia commonly experienced in people with type 1 diabetes, URLi provided a faster recovery versus Humalog from a missed mealtime bolus or during basal insulin suspension. URLi shows significant acceleration of insulin absorption versus Humalog when boluses are administered by subcutaneous infusion or injection.
在一项随机、双盲交叉研究中，比较超快速赖脯胰岛素（URLi；Lyumjev®）与优泌乐相比，血糖恢复正常所需的时间。
32名接受持续皮下胰岛素输注治疗的1型糖尿病成年患者参与两个阶段的研究：每个阶段包括因错过餐时推注胰岛素导致的高血糖（第1天）和因暂停基础胰岛素输注导致的高血糖（第2天）。当出现高血糖[血浆葡萄糖（PG）>240mg/dl]时，给予URLi或优泌乐的校正推注剂量，并比较血糖恢复正常（PG = 140mg/dl）所需的时间、药代动力学和糖动力学。
错过餐时推注胰岛素后，与优泌乐相比，URLi显著降低了最高血糖值（-13mg/dl；p = 0.02），血糖下降速度在数值上更快（23mg/dl/h；p = 0.07），从高血糖状态恢复得更快（-23分钟；p = 0.1），尽管差异不显著。基础胰岛素输注暂停后，与优泌乐相比，URLi显著降低了最高血糖值（-6mg/dl；p = 0.02），血糖下降速度更快（24mg/dl/h；p < 0.001），从高血糖状态恢复得更快（-16分钟；p < 0.01）。给予URLi校正推注剂量后，与优泌乐相比，观察到赖脯胰岛素的吸收加速：皮下输注（第1天）或注射（第2天）给予校正推注剂量后，早期50%达峰时间分别缩短了6或12分钟，0-15分钟的曲线下面积分别增加了2.5倍或4.3倍（所有p < 0.001）。
在1型糖尿病患者常见的高血糖发作期间，与优泌乐相比，URLi在错过餐时推注胰岛素或基础胰岛素输注暂停期间能更快恢复血糖正常。当通过皮下输注或注射给予推注剂量时，URLi显示出与优泌乐相比胰岛素吸收显著加速。
