Pharmacokinetic and pharmacodynamic bioequivalence of biosimilar MYL-1601D with US and European insulin aspart in healthy volunteers: A randomized, double-blind, crossover, euglycaemic glucose clamp study

What Was Tested

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

Who Took Part

The study group was 71 subjects.

How the Study Was Run

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

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

As a double-blind Insulin Aspart study, the assignments were hidden from both participants and investigators until the end.

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

Primary PK endpoints were area under the plasma insulin aspart concentration-time curve from 0 to 12 hours (AUC0-12h ) and maximum plasma insulin aspart concentration (Cmax ).

Primary PD endpoints were area under the glucose infusion rate (GIR) time curve from 0 to 12 hours (AUCGIR0-12h ) and maximum GIR (GIRmax ).

Insulin aspart in plasma was quantified using immunoaffinity purification followed by ultraperformance liquid chromatography and tandem mass spectrometric detection.

What Was Measured

The subject headings attached to it are Area Under Curve, Glucose, Glucose Clamp Technique, Healthy Volunteers, Hypoglycemic Agents, Insulin Aspart and Therapeutic Equivalency.

The authors tagged it with the keywords biosimilar and euglycaemic clamp study.

What This Means in Plain Language

The paper is a randomized, double-blind and crossover study of Insulin Aspart in 71 subjects.

Its findings take up roughly 4 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.

The publication is from 2021 (Diabetes, obesity & metabolism), a journal based in England.

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