Safety of Insulin Lispro and a Biosimilar Insulin Lispro When Administered Through an Insulin Pump

What Was Tested

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

SAR342434 (U100; SAR-Lis; insulin lispro) is a biosimilar/follow-on to insulin lispro (U100; Ly-Lis).

The current study evaluated the safety of SAR-Lis and Ly-Lis when administered by continuous subcutaneous insulin infusion (CSII; insulin pumps).

Who Took Part

The abstract describes 27 patients taking part.

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

This was a randomized, open-label, 2 × 4-week, two-arm crossover study in 27 patients with type 1 diabetes mellitus (NCT02603510).

Secondary outcomes included intervals between infusion set changes, treatment-emergent adverse events (TEAEs) including infusion site, hypersensitivity reactions and hypoglycemic events, and safety.

How the Study Was Run

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

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

Being open-label, the Insulin Lispro study did not mask who received what.

In the crossover set-up each of the patients took both Insulin Lispro and the comparison in turn, acting as their own control.

What Was Measured

The current study evaluated the safety of SAR-Lis and Ly-Lis when administered by continuous subcutaneous insulin infusion (CSII; insulin pumps).

Topics PubMed links to this paper include Diabetes Mellitus, Type 1, Equipment Failure, Hypoglycemic Agents, Insulin Infusion Systems and Insulin Lispro.

The authors tagged it with the keywords SAR342434, biosimilar, continuous subcutaneous insulin infusion, infusion set occlusion and type 1 diabetes mellitus.

What This Means in Plain Language

The paper is a randomized, open-label and crossover study of Insulin Lispro in 27 patients.

With fewer than 40 people, it is a small study, so it is better read as an early signal for further research than as a settled answer.

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 2018 (Journal of diabetes science and technology), a journal based in United States.

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