Pharmacokinetic and pharmacodynamic similarity between SAR341402 insulin aspart and Japan-approved NovoRapid in healthy Japanese subjects

What Was Tested

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

Primary endpoints were maximum plasma insulin aspart concentration (INS-Cmax), area under the plasma insulin concentration-time curve to the last quantifiable concentration (INS-AUClast), area under the GIR-time curve during the clamp (GIR-AUC0-10 h), and maximum GIR (GIRmax).

Who Took Part

By PubMed's age tags, the people studied were young adults, adults and middle-aged adults, men only.

Forty subjects were randomized with 39 completing both treatment periods.

How the Study Was Run

In design terms this was a randomized, double-blind and crossover study.

Because people in this Insulin Aspart 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 Aspart, so expectations could not easily colour the readings.

Each person switched between Insulin Aspart and the comparison at some point, usually with a gap in between.

Plasma insulin aspart concentrations and blood glucose levels were measured, and glucose infusion rates (GIRs) were assessed.

What Was Measured

Primary endpoints were maximum plasma insulin aspart concentration (INS-Cmax), area under the plasma insulin concentration-time curve to the last quantifiable concentration (INS-AUClast), area under the GIR-time curve during the clamp (GIR-AUC0-10 h), and maximum GIR (GIRmax).

PubMed files the paper under topics including Biomarkers, Blood Glucose, Healthy Volunteers, Hypoglycemic Agents, Insulin Aspart, Japan and Therapeutic Equivalency.

What This Means in Plain Language

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

The publication is from 2021 (Scientific reports), a journal based in England.

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