Similar Pharmacokinetics and Pharmacodynamics of Biosimilar SAR342434 Insulin Lispro and Japan-Approved Humalog Insulin Lispro in Healthy Japanese Subjects

What Was Tested

The paper reports a study of Insulin Lispro, published as a randomized controlled trial.

This was a randomized, double-blind, 2-period, crossover study.

Primary PK end points were maximum plasma insulin lispro concentration and area under the plasma insulin concentration-time curve (AUC) from time 0 to the last quantifiable concentration.

Who Took Part

PubMed tags the participants as men only.

How the Study Was Run

The researchers set it up as a randomized, double-blind and crossover study.

Because people in this Insulin Lispro study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Neither the participants nor the staff measuring them knew who was on Insulin Lispro, so expectations could not easily colour the readings.

In the crossover set-up each of the participants took both Insulin Lispro and the comparison in turn, acting as their own control.

Insulin lispro concentration and blood glucose were measured, and the glucose infusion rate (GIR) was adjusted to maintain the target blood glucose level.

What Was Measured

Primary PK end points were maximum plasma insulin lispro concentration and area under the plasma insulin concentration-time curve (AUC) from time 0 to the last quantifiable concentration.

Primary PD end points were area under the GIR-time curve from time 0 to 10 hours and maximum GIR.

PubMed files the paper under topics including Blood Glucose, Glucose, Hypoglycemic Agents, Insulin Lispro and Japan.

The authors tagged it with the keywords SAR342434, biosimilar, healthy Japanese subjects and insulin analog.

What This Means in Plain Language

The paper is a randomized, double-blind and crossover study of Insulin Lispro.

The publication is from 2022 (Clinical pharmacology in drug development), a journal based in United States.

More context: the Insulin Lispro compound page, all human trials.