Pharmacokinetic similarity of switching SAR341402 insulin aspart biosimilar and NovoLog insulin aspart versus continuous use of NovoLog in adults with type 1 diabetes: The GEMELLI X trial

What Was Tested

Researchers studied Insulin Glargine and Insulin Aspart in this randomized controlled trial publication.

Who Took Part

The abstract describes 210 subjects taking part.

The age groups tagged for this paper are adults.

This multicentre, open-label, phase 3 study randomized (1:1) 210 subjects with T1D treated with once-daily insulin glargine U100 as basal insulin to four 4-week periods of alternating multiple daily injections of SAR-Asp and NN-Asp (NN-Asp for the first 4 weeks, SAR-Asp in the last 4 weeks; switching group) versus 16 weeks of continuous NN-Asp (non-switching group).

How the Study Was Run

The design is described as randomized, open-label and multicenter.

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

Everyone knew when Insulin Glargine was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

More than one site took part, so the subjects came from several places.

What Was Measured

PubMed files the paper under topics including Blood Glucose, Diabetes Mellitus, Type 1, Hypoglycemic Agents, Insulin, Insulin Aspart and Insulin Glargine.

Author keywords: GEMELLI X, SAR341402, biosimilar, interchangeability and switches (max. 6).

What This Means in Plain Language

The paper is a randomized, open-label and multicenter study of Insulin Glargine and Insulin Aspart in 210 subjects.

Its findings take up roughly 6 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.

The publication is from 2024 (Diabetes, obesity & metabolism), a journal based in England.

More context: the Insulin Glargine compound page and the Insulin Aspart compound page.