Comparative assessment of immunogenicity of recombinant insulin Aspart from BioGenomics and its originator NovoRapid® in adult patients with type 2 diabetes mellitus

What Was Tested

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

The primary objective of the study was to compare the immunogenicity of BGL-ASP and RMP; NovoRapid® in patient serum samples collected from phase-III clinical study.

Statistical evaluation was done by Fisher's exact test to compare the overall incidence of patients positive for AIA antibodies and the TEAR positives observed post-baseline in both the treated groups.

Who Took Part

PubMed indexes the participants as adults, middle-aged adults and older adults, both men and women.

How the Study Was Run

The researchers set it up as a randomized, open-label, multicenter and parallel-group study.

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

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.

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

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

An in-vitro neutralizing antibody assay (Nab assay) was also performed to study the effect of AIA antibodies in neutralizing the biological activity/metabolic function of the insulin.

The researchers also evaluated the association between AIA antibody levels and its impact on biological activity by studying the correlation between them.

What Was Measured

The subject headings attached to it are Diabetes Mellitus, Type 2, Insulin Aspart, Hypoglycemic Agents, Blood Glucose, Insulin Antibodies and Glycated Hemoglobin.

Author keywords: Anti-insulin aspart antibodies, Biosimilars, Glucose uptake, Immunogenicity, Neutralizing antibodies and Treatment emergent antibody response.

What This Means in Plain Language

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

Results are reported in around 6 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2024 (Journal of endocrinological investigation), a journal based in Italy.

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