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Bioequivalence and comparative pharmacodynamics of insulin lispro 200 U/mL relative to insulin lispro (Humalog®) 100 U/mL

Content Provider	Scilit
Author	de la Peña, Amparo Seger, Mary Soon, Danny Scott, Adam J. Reddy, Shobha R. Dobbins, Michael A. Brown‐Augsburger, Patricia Linnebjerg, Helle
Copyright Year	2015
Description	Journal: Clinical Pharmacology in Drug Development Insulin lispro 200 U/mL (IL200) is a new strength formulation of insulin lispro (Humalog®, IL100), developed as an option for diabetic patients on higher daily mealtime insulin doses. This phase 1, open‐label, 2‐sequence, 4‐period crossover, randomized, 8‐hour euglycemic clamp study aimed to demonstrate the bioequivalence of IL200 and IL100 after subcutaneous administration of 20 U (U) to healthy subjects (n = 38). Pharmacokinetic (PK) and pharmacodynamic (PD) responses were similar in both formulations. All 90%CIs for the ratios of area under the concentration‐versus‐time curve from time zero to the time of the last measurable concentration (AUC0–tlast) and maximum observed drug concentration (Cmax), as well as the total glucose infused throughout the clamp (Gtot) and the maximum glucose infusion rate (Rmax), were contained within 0.80 and 1.25. Time of maximum observed drug concentration (tmax) was similar between formulations, with a median difference of 15 minutes and a 95%CI of the difference that included zero. Inter‐ and intrasubject variability estimates were similar for both formulations. Both formulations were well tolerated. IL200 was bioequivalent to IL100 after subcutaneous administration of 20‐U single doses, and PD responses were comparable between formulation strengths.
Related Links	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5054907/pdf
Ending Page	75
Page Count	7
Starting Page	69
e-ISSN	21607648
DOI	10.1002/cpdd.221
Journal	Clinical Pharmacology in Drug Development
Issue Number	1
Volume Number	5
Language	English
Publisher	Wiley-Blackwell
Publisher Date	2015-10-05
Access Restriction	Open
Subject Keyword	Journal: Clinical Pharmacology in Drug Development Biotechnology and Microbiology Diabetes Mellitus
Content Type	Text
Resource Type	Article

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