Faster Recovery from Hyperglycemia with Ultra Rapid Lispro (URLi) vs Insulin Lispro in Patients with Type 1 Diabetes (T1D) on Continuous Subcutaneous Insulin Infusion (CSII)

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Background and aims Ultra Rapid Lispro (URLi) is a novel insulin lispro formulation developed to more closely match physiological insulin secretion. aim of the study was to assess the time of recovery from hyperglycemia following administration of URLi compared to Lispro. Methods This randomized, double-blind, 2-period, crossover study compared pharmacokinetics and glucodynamics of URLi vs insulin lispro during recovery from hyperglycemia (plasma glucose [PG] > 240 mg/dL) due to missed meal bolus or basal insulin suspension in 32 adults with T1D on CSII. Results Following a missed meal bolus, a correction dose of URLi reduced maximum PG (-13 mg/dL; p=0.02), produced more rapid decline in PG (23 mg/dL/hr; p=0.07), and achieved recovery (PG 140 mg/dL) 23 min earlier (p=0.1) vs Lispro. Similar results were observed during recovery of hyperglycemia due to basal suspension: a correction dose of URLi reduced maximum PG (-6 mg/dL; p=0.02), produced faster PG decline (24 mg/dL/hr; p<0.001), and achieved recovery 16 min earlier (p=0.001) vs insulin lispro. The early 50% tmax for insulin lispro occurred sooner (-6 or -12 min; p<0.001), and early insulin exposure was greater (2.5 or 4.3 fold, AUC0-15min; 1.7 or 2.5 fold AUC0-30min; both p<0.001), with URLi vs insulin lispro after correction bolus for a missed meal bolus or basal insulin suspension, respectively. Conclusion During episodes of hyperglycemia commonly experienced by patients with T1D, a correction dose of URLi provided faster recovery vs insulin lispro, reflective of the faster insulin absorption. Publication History Article published online: 26 May 2022 © 2022. Thieme. All rights reserved. Georg Thieme Verlag KG Rüdigerstraße 14, 70469 Stuttgart, Germany

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