A Trial to Evaluate the Pharmacokinetic and Pharmacodynamic Properties of BioChaperone® Insulin Lispro, Fiasp® and NovoRapid® Delivered by an Insulin Pump

What Was Tested

In this phase 1 trial, researchers set out to test Insulin Aspart and Insulin Lispro.

It had three arms (groups): BioChaperone® insulin lispro (experimental), Fiasp® (active comparator) and Novorapid® (active comparator).

Single subcutaneous administration of BioChaperone® insulin lispro.

Single subcutaneous administration of Fiasp® (insulin aspart).

Single subcutaneous administration of Novorapid® (insulin aspart).

The registry classes the interventions as drug.

Who Took Part

43 actual participants took part.

It was open to people of any sex aged from 18 years up to 64 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Type 1 Diabetes Mellitus for more than 12 months. BMI between 18.5 and 28.5 kg/m².

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: type 2 diabetes mellitus; history of multiple and/or severe allergies to drugs or foods; more than one episode of severe hypoglycaemia with seizure, coma or requiring assistance of another person during the past 6 months.

How the Study Was Run

Design: randomized, crossover and quadruple-blind.

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

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

Blinding on both sides kept the participants and researchers unaware of who received Insulin Aspart.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2017-06-20 with completion listed for 2017-09-27.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: AUCGIR(0-60min) (time frame: 60 minutes).

It also tracked 9 secondary outcomes, for example AUCins(0-30min), AUCins(0-60min), AUCins(0-600min), Cmax insulin, Tmax insulin and TmaxGIR.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Aspart and Insulin Lispro in 43 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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