A randomized pharmacokinetic and pharmacodynamic trial of two regular human insulins demonstrates bioequivalence in type 1 diabetes and availability of biosimilar insulin may improve access to this medication

• Published in: Diabetes, obesity & metabolism Vol. 24; no. 8; pp. 1544 - 1552
• Main Authors: Vencio, Sérgio, Caiado‐Vencio, Rafael, Caixeta, Leonardo Ferreira, Masierek, Małgorzata, Mlynarski, Wojciech, Drzewoski, Józef, Gregory, Justin M.
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Publishing Ltd 01.08.2022; Wiley Subscription Services, Inc
• Subjects: Biological products; Biosimilar Pharmaceuticals - adverse effects; Body mass index; Cross-Over Studies; Diabetes; Diabetes mellitus (insulin dependent); Diabetes Mellitus, Type 1 - drug therapy; Double-Blind Method; Glucose - therapeutic use; Glucose Clamp Technique; Humans; Hypoglycemic Agents; Insulin; insulin therapy; Insulin, Isophane - therapeutic use; Insulin, Regular, Human - therapeutic use; Pharmacodynamics; Pharmacokinetics; Therapeutic Equivalency; type 1 diabetes; pharmacokinetics; type 1 diabetes; insulin therapy; pharmacodynamics

Aims To compare the pharmacokinetic (PK) and pharmacodynamic (PD) effects and safety of therapeutic dosages of a regular insulin (experimental drug) produced by Bioton S.A. (Warsaw, Poland) versus Humulin® R, a regular insulin (reference drug) produced by Eli Lilly (Indianapolis, Indiana). Materials...