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Ultra rapid lispro (URLi) shows faster pharmacokinetics and reduces postprandial glucose excursions vs Humalog in patients with type 2 diabetes mellitus in a randomized, controlled crossover meal test early‐phase study

Diabetes, Obesity and Metabolism Nov 02, 2021

Leohr J, Kazda C, Liu R, et al. - When administered to treat type 2 diabetes mellitus (T2D), ultra rapid lispro (URLi) not only showed good tolerability but also resulted in accelerated insulin lispro absorption and greater postprandial glucose reduction at different meal-to-dose timings vs Humalog.

  • A two-part, randomized, double-blind Phase 1b study to compare single and multiple daily subcutaneous doses of URLi vs Humalog for T2D.

  • Elevation in insulin exposure by 2.2-fold and decrease in the time to the early half-maximal drug concentration by 22.6% was observed with URLi vs Humalog.

  • In comparing the same meal-to-dose timing between the insulins, significant reduction by 29%-105% in postprandial glucose excursion over 5 hours was achieved with all three dose timings (15 minutes before, immediately before, or 15 minutes after the start of the meal) with URLi.

  • Following daily subcutaneous dosing for 2 weeks, sustained pharmacokinetics and glucodynamics were observed.

  • During the mixed meal tolerance tests, more hypoglycemic events occurred due to URLi; there were few events with both treatments during the 2 weeks of outpatient dosing.

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