Bioequivalence of Ultra Rapid Lispro (URLi) U100 and U200 Formulations in Healthy Subjects.

Diabetes Therapy : Research, Treatment and Education of Diabetes and Related Disorders
Helle LinnebjergJennifer Leohr

Abstract

Ultra rapid lispro (URLi) is a novel insulin lispro formulation that was developed to more closely match physiological insulin secretion. The aims of this study were to demonstrate the bioequivalence (BE) of a concentrated formulation (U200) of URLi to the U100 formulation of URLi after subcutaneous (SC) administration and to evaluate the glucodynamics (GD) of these formulations. This phase 1, randomized, two-sequence, four-period, double-blind, replicate crossover study was conducted in 68 healthy subjects. At each dosing visit, subjects received a 15-U SC dose of either U100 URLi or U200 URLi followed by a 10-h euglycemic clamp procedure. Serum insulin lispro and blood glucose concentrations were measured, and the glucose infusion rate was continuously adjusted during the clamp to maintain the target blood glucose. Bioequivalence of U200 URLi relative to U100 URLi was demonstrated. The 90% confidence intervals (CIs) of the ratios of geometric least squares (LS) means for the maximum insulin concentration and total exposure were within the BE limits of 0.80-1.25. Additionally, the 90% CIs for the ratios of geometric LS means for maximum glucose infusion rate and total glucose infused were within the BE limits. The early 50% tm...Continue Reading

References

Dec 5, 2014·Saudi Pharmaceutical Journal : SPJ : the Official Publication of the Saudi Pharmaceutical Society·Upendra C GalgattePravin D Chaudhari
Jul 12, 2017·Nature Medicine·Michael P Czech
Sep 29, 2018·Journal of Diabetes·Lutz HeinemannSheila M Corrigan
Jan 19, 2019·Diabetes Technology & Therapeutics·Nicole C FosterSatish K Garg
Dec 25, 2019·Diabetes Therapy : Research, Treatment and Education of Diabetes and Related Disorders·Antonio NicolucciMarco Orsini Federici

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Methods Mentioned

BETA
enzyme-linked immunosorbent assay

Clinical Trials Mentioned

NCT03616977

Software Mentioned

S PLUS
Phoenix
SAS

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