Pharmacokinetic and pharmacodynamic similarity evaluation between an insulin glargine biosimilar product and Lantus^® in healthy subjects: Pharmacokinetic parameters of both parent insulin glargine and M1 were used as endpoints.

ABSTRACT: Insulin glargine is a long-acting insulin analog, which plays an important role in the treatment of diabetes mellitus. Biosimilar products of insulin glargine can provide patients with additional safe, high-quality, and potentially cost-effective options for treating diabetes. This article presents a randomized, double-blind, single-dose, two-treatment, four-period, replicate crossover, euglycemic clamp study which was designed to evaluate the PK and PD similarity between the recombinant insulin glargine developed by Wanbang (test) and Lantus^® (reference) in healthy volunteers. Subjects received subcutaneous administration of the insulin glargine formulation (0.4 U/kg) on two occasions for the test and reference drug, respectively, and a 20% dextrose solution was infused at vari

SUBMITTER: Wang Y 

PROVIDER: S-EPMC9459017 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature