Abstract
AimTo compare the pharmacokinetics (PK), glucodynamics (GD), and tolerability following single and multiple daily subcutaneous (SC) doses of ultra rapid lispro (URLi) and Humalog® in patients with type 1 diabetes mellitus (T1D).Materials and MethodsThis was a two‐part, randomized, double‐blind, Phase 1b study. Part A used a six‐period crossover design to assess PK and GD response to a solid mixed meal tolerance test (MMTT) following a single dose of URLi or Humalog administered 15 min before, immediately before, and 15 min after the start of the meal. Part B evaluated URLi or Humalog during 2 weeks of multiple daily dosing with a parallel design. The PK and GD were assessed following MMTTs at the beginning and end of the 2‐week period when insulins were administered immediately before the start of the meal.ResultsURLi increased the insulin exposure within the first 30 min postdose by 2.2‐fold and reduced the time to early half‐maximal drug concentration by 37% compared with Humalog. Overall, URLi resulted in better postprandial glucose lowering when dosed before, immediately before, or after a meal compared with Humalog. Comparing the same meal‐to‐dose timing between the insulins, postprandial glucose excursion over 5 hours was reduced by 40%‐44% for all three dose timings (−15, 0, and +15 min) with URLi, achieving statistical significance for the 0‐ and +15‐min timings. The PK and GD profiles were sustained after daily SC dosing for 2 weeks in patients with T1D. The number of documented hypoglycaemic events was similar between URLi and Humalog during the postprandial period of the MMTTs and the outpatient period.ConclusionsURLi showed accelerated insulin lispro absorption and greater postprandial glucose reduction at different meal‐to‐dose timings compared with Humalog and was well tolerated in patients with T1D.
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