Single-Dose Euglycemic Clamp Study Demonstrating Pharmacokinetic and Pharmacodynamic Similarity Between SAR341402 Insulin Aspart and US- and EU-Approved Versions of Insulin Aspart in Subjects with Type 1 Diabetes

What Was Tested

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

Primary endpoints were area under the plasma insulin concentration-time curve from time zero to the last quantifiable concentration (INS-AUClast), and extrapolated to infinity (INS-AUCinf), maximum plasma insulin concentration (INS-Cmax), and the area under the body weight-standardized glucose infusion rate (GIR)-time curve from 0 to 12 hours (GIR-AUC0-12h) among the three treatments.

GIRmax was the main secondary endpoint.

Who Took Part

The abstract describes 30 subjects taking part.

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

How the Study Was Run

The design is described as randomized, double-blind and crossover.

The subjects were allocated by chance, so the Insulin Aspart group and the comparison group should start out alike.

Blinding on both sides kept the subjects and researchers unaware of who received Insulin Aspart.

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

What Was Measured

Primary endpoints were area under the plasma insulin concentration-time curve from time zero to the last quantifiable concentration (INS-AUClast), and extrapolated to infinity (INS-AUCinf), maximum plasma insulin concentration (INS-Cmax), and the area under the body weight-standardized glucose infusion rate (GIR)-time curve from 0 to 12 hours (GIR-AUC0-12h) among the three treatments.

GIRmax was the main secondary endpoint.

Topics PubMed links to this paper include Blood Glucose, Diabetes Mellitus, Type 1, European Union, Glucose Clamp Technique, Hypoglycemic Agents, Insulin Aspart and United States.

Author keywords: Biosimilar, Phase I study and Type 1 diabetes.

What This Means in Plain Language

The paper is a randomized, double-blind and crossover study of Insulin Aspart in 30 subjects.

With fewer than 40 people, it is a small study, so it is better read as an early signal for further research than as a settled answer.

The publication is from 2020 (Diabetes technology & therapeutics), a journal based in United States.

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