Safety and Efficacy of Switching SAR341402 Insulin Aspart and Originator Insulin Aspart vs Continuous Use of Originator Insulin Aspart in Adults With Type 1 Diabetes: The GEMELLI X Trial

What Was Tested

This randomized controlled trial paper looks at Insulin Aspart.

GEMELLI X was a randomized controlled trial to assess outcomes with a biosimilar in line with the US Food and Drug Administration requirements for designation as an interchangeable biosimilar.

Why It Was Studied

SAR341402 insulin aspart (SAR-Asp) is a rapid-acting insulin analog developed as an interchangeable biosimilar to the marketed insulin aspart reference product (NovoLog; NN-Asp).

Who Took Part

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

How the Study Was Run

In design terms this was a randomized, open-label and parallel-group 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.

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

This open-label randomized (1:1), parallel-group, phase 3 trial compared four × four weeks of alternating use of individually titrated SAR-Asp and NN-Asp (NN-Asp for first four weeks, SAR-Asp in last four weeks; switching group) vs 16 weeks of continuous use of NN-Asp (nonswitching group).

What Was Measured

Topics PubMed links to this paper include Diabetes Mellitus, Type 1, Insulin Aspart, Hypoglycemic Agents, Blood Glucose, Glycated Hemoglobin, Hypoglycemia and Drug Substitution.

The authors tagged it with the keywords GEMELLI X, SAR341402, biosimilar and interchangeable.

What This Means in Plain Language

The paper is a randomized, open-label and parallel-group study of Insulin Aspart.

Results are reported in around 5 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2025 (Journal of diabetes science and technology), a journal based in United States.

More context: the Insulin Aspart compound page.