Safety and Tolerability of Insulin Aspart Biosimilar SAR341402 Versus Originator Insulin Aspart (NovoLog) When Used in Insulin Pumps in Adults with Type 1 Diabetes: A Randomized, Open-Label Clinical Trial

What Was Tested

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

Why It Was Studied

Materials and Methods: This randomized, open-label, 2 × 4-week crossover study enrolled 45 adults with type 1 diabetes (T1D).

Who Took Part

The abstract describes 45 adults taking part.

The age groups tagged for this paper are adults, middle-aged adults and older adults, both men and women.

Participants were randomized 1:1 to the treatment sequence SAR-Asp/NN-Asp or NN-Asp/SAR-Asp.

How the Study Was Run

The researchers set it up as a randomized, open-label and crossover study.

Random assignment meant chance, not the researchers, decided who got Insulin Aspart and who got the comparison, which limits bias.

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.

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

What Was Measured

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

Author keywords: Biosimilar, Continuous subcutaneous insulin infusion, Follow-on product, Infusion set occlusion and SAR341402.

What This Means in Plain Language

The paper is a randomized, open-label and crossover study of Insulin Aspart in 45 adults.

The publication is from 2020 (Diabetes technology & therapeutics), a journal based in United States.

More context: the Insulin Aspart compound page.