Ultra rapid lispro (URLi) shows accelerated pharmacokinetics and greater reduction in postprandial glucose versus Humalog® in patients with type 1 diabetes mellitus in a randomized, double‐blind meal test early‐phase study

• DOI: 10.1111/dom.14563
• Publication Date: 2021-10-01T02:52:09Z
• Authors: Christof Kazda; Jennifer Leohr; Rong Liu; Shobha Reddy; Mary Anne Dellva; Mei Teng Loh; Thomas Hardy; Leona Plum‐Mörschel
• Keywords: Insulin lispro; Crossover study; Tolerability

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