Investigation of Pump Compatibility of Fast-Acting Insulin Aspart in Subjects With Type 1 Diabetes

Eric Zijlstra, Marek Demissie, Tina Graungaard, Tim Heise, Leszek Nosek, Bruce Bode, Eric Zijlstra, Marek Demissie, Tina Graungaard, Tim Heise, Leszek Nosek, Bruce Bode

Abstract

Background: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

Keywords: infusion set occlusion; insulin pump; rapid-acting insulin; safety; type 1 diabetes mellitus.

Conflict of interest statement

Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: EZ has received travel grants and speaker fees from Dance Biopharm, Novo Nordisk, and Roche Diabetes Care. MD and TG are employees of Novo Nordisk and hold shares with the company. TH is shareholder of Profil, a private research institute that received research funds from Adocia, Biocon, Dance Pharmaceuticals, Eli Lilly, Johnson & Johnson, Julphar, Medimmune, Mylan, Nordic Bioscience, Novo Nordisk, Poxel, Roche Diagnostics, Saniona, Sanofi, Senseonics, SkyPharma, and Zealand Pharma. In addition, TH received speaker honoraria from Eli Lilly and Novo Nordisk and fees for the participation in Advisory Boards from Novo Nordisk. LN has no potential conflicts of interest to disclose. BB holds shares with Aseko; has received speaker fees from AstraZeneca, Eli Lilly/Boehringer Ingelheim, Insulet, Janssen, Medtronic, Novo Nordisk, and Sanofi; has acted as a consultant to Adocia, Janssen, Medtronic, Mannkind, Novo Nordisk, and Sanofi; and receives grant and research support from Abbott, Becton Dickinson, DexCom, GSK, Janssen, Lexicon, Eli Lilly/Boehringer Ingelheim, Medtronic, NIH, Novo Nordisk, Sanofi, and Senseonics.

Figures

Figure 1.
Figure 1.
Evaluation of infusion sets.
Figure 2.
Figure 2.
Nine-point SMPG profiles at (A) baseline and (B) week 6. SMPG, self-measured plasma glucose.

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