Ultra rapid lispro showed greater reduction in postprandial glucose versus Humalog in children, adolescents and adults with type 1 diabetes mellitus

Abstract

AbstractAimThis study compared the pharmacokinetics, glucodynamics and tolerability following single subcutaneous doses of ultra rapid lispro (URLi) versus Humalog in children (6‐11 years), adolescents (12‐17 years) and adults (18‐64 years) with type 1 diabetes mellitus (T1D).Materials and MethodsThe study was a randomized, two‐period, subject‐ and investigator‐blind, crossover design in participants with T1D. Participants received a 0.2 U/kg bolus dose immediately before a liquid mixed meal tolerance test. Insulin lispro and glucose concentrations were measured.ResultsThe study included 13 children, 14 adolescents and 15 adults. Consistently across the age groups, onset of appearance was 4‐5 min faster, the early 50% tmax was reduced by 7‐13 min, and exposure in the first 15 min was increased by 3.5‐6.5‐fold following URLi compared with Humalog (all p < .01). Exposure after 3 h was decreased by 37‐58% (p = .02) and the duration was reduced by 56 min (p = .006) in children and 36 min (p = .022) in adolescents with URLi compared with Humalog. The maximum and overall exposure were similar between treatments. Postprandial glucose at 1 h was reduced by 42 mg/dl in children (p = .008), 19 mg/dl (p = .195) in adolescents and 34 mg/dl (p = .018) in adults following URLi versus Humalog. The glucose excursion during a 5‐h test meal period was reduced by 16% in children and 9% in adolescents compared with Humalog. URLi was well tolerated in all age groups.ConclusionsURLi showed an accelerated insulin lispro absorption and greater postprandial glucose reduction compared with Humalog in children, adolescents and adults with T1D.