Anti-Insulin Antibodies and Adverse Events with Biosimilar Insulin Lispro Compared with Humalog Insulin Lispro in People with Diabetes

What Was Tested

Researchers studied Insulin Lispro in this randomized controlled trial publication.

SAR342434 (SAR-Lis) is a biosimilar (follow-on) of insulin lispro (Humalog®; Ly-Lis).

SORELLA 1 was a 12-month study in 507 people with type 1 diabetes mellitus (T1DM); SORELLA 2 was a 6-month study in 505 people with type 2 diabetes mellitus (T2DM).

Who Took Part

The abstract describes 507 people taking part.

PubMed indexes the participants as teenagers, young adults, adults, middle-aged adults, older adults and people over 80, both men and women.

AIA were measured regularly throughout both studies at a centralized laboratory blinded to treatment groups using a drug-specific AIA assay.

How the Study Was Run

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

Because people in this Insulin Lispro 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 Lispro was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

The Insulin Lispro group and the comparison group ran side by side rather than switching.

The AIA status (positive or negative), AIA titers, and cross-reactivity to human insulin, insulin glargine, and insulin glargine metabolite M1 were analyzed.

What Was Measured

Topics PubMed links to this paper include Blood Glucose, Diabetes Mellitus, Type 1, Glycated Hemoglobin, Insulin Antibodies and Insulin Lispro.

The authors tagged it with the keywords Anti-insulin antibodies, Biosimilar, Immunogenicity and SAR342434.

What This Means in Plain Language

The paper is a randomized, open-label and parallel-group study of Insulin Lispro in 507 people.

With several hundred people or more, it is a fairly large study for this kind of research.

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 2018 (Diabetes technology & therapeutics), a journal based in United States.

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