Zijlstra Eric, Demissie Marek, Graungaard Tina, Heise Tim, Nosek Leszek, Bode Bruce
1 Profil, Neuss, Germany.
2 Novo Nordisk A/S, Søborg, Denmark.
J Diabetes Sci Technol. 2018 Jan;12(1):145-151. doi: 10.1177/1932296817730375. Epub 2017 Sep 18.
Ultra-fast-acting insulins, such as fast-acting insulin aspart (faster aspart), have pharmacokinetic properties that may be advantageous for patients using continuous subcutaneous insulin infusion (CSII), provided that they are compatible with and safe to use in CSII.
Randomized, double-blind, parallel-group, actively controlled trial evaluating compatibility, efficacy, and safety of faster aspart in adults with type 1 diabetes using their own MiniMed Paradigm pump with Quick-Set or Silhouette infusion sets. Following run-in, subjects were randomized (2:1) to faster aspart (n = 25) or insulin aspart (n = 12) for 6 weeks. Primary endpoint was the number of microscopically confirmed episodes of infusion-set occlusions.
No microscopically confirmed episodes of infusion-set occlusions were observed in either arm. Seven possible infusion-set occlusions were reported by five subjects (all faster aspart); none were prompted by a plug observed by the subject (prompted by unexplained hyperglycemia [n = 6] or leakage [n = 1]) and none were confirmed. Macroscopic and microscopic evaluation showed no color change or particle/crystal formation in the infusion sets. Premature infusion-set changes were reported in 44% and 16.7% of subjects in the faster aspart and insulin aspart groups, respectively. A nonsignificant trend toward better efficacy was observed with faster aspart (estimated treatment difference [ETD] [95% CI] in HbA1c change: -0.14% [-0.40, 0.11]). No new safety issues were found in either treatment group.
Over 6 weeks of treatment, no microscopically confirmed infusion-set occlusions were observed for faster aspart or insulin aspart, indicating similar compatibility with CSII use.
超短效胰岛素，如门冬胰岛素（起效更快的门冬胰岛素），具有药代动力学特性，对于使用持续皮下胰岛素输注（CSII）的患者可能具有优势，前提是它们与CSII兼容且使用安全。
随机、双盲、平行组、活性对照试验，评估起效更快的门冬胰岛素在1型糖尿病成人患者中使用其自带的带有快速设定或轮廓输注装置的美敦力Paradigm泵时的兼容性、疗效和安全性。在导入期后，受试者被随机分配（2:1）至起效更快的门冬胰岛素组（n = 25）或门冬胰岛素组（n = 12），为期6周。主要终点是显微镜确诊的输注装置堵塞事件的数量。
两组均未观察到显微镜确诊的输注装置堵塞事件。五名受试者（均为起效更快的门冬胰岛素组）报告了七起可能的输注装置堵塞事件；均非由受试者观察到的堵塞物引起（由不明原因的高血糖症引起[n = 6]或渗漏引起[n = 1]），且均未得到证实。宏观和微观评估显示输注装置中无颜色变化或颗粒/晶体形成。起效更快的门冬胰岛素组和门冬胰岛素组分别有44%和16.7%的受试者报告了过早的输注装置更换。起效更快的门冬胰岛素显示出疗效更好的非显著趋势（糖化血红蛋白变化的估计治疗差异[ETD][95%CI]：-0.14%[-0.40, 0.11]）。两个治疗组均未发现新的安全问题。
在6周的治疗过程中，起效更快的门冬胰岛素或门冬胰岛素均未观察到显微镜确诊的输注装置堵塞事件，表明它们与CSII使用具有相似的兼容性。
