A Trial Investigating the Continuous Subcutaneous Insulin Infusion of a Liquid Formulation of BioChaperone Insulin Lispro in Comparison to Humalog®

What Was Tested

The trial (phase 1) is built around Insulin Lispro.

This study is constituted of 2 parts: Part A: A total of 36 patients will be enrolled in part A.

Each treatment period consists of 10 treatment days under free living conditions (e.g. home / workplace) and under standardised conditions at the clinic.

It had two arms (groups): BioChaperone insulin lispro (experimental) and Humalog® (active comparator).

Insulin lispro.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 80 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 for at least 12 months. Body Mass Index (BMI) between 18.5 and 28.5 kg/m\^2, both inclusive.

The full record lists 7 inclusion and 12 exclusion criteria; among the exclusions: known or suspected hypersensitivity to investigational medicinal product(s) (imp(s)) or related products; type 2 diabetes mellitus; previous participation in this trial.

How the Study Was Run

It was run as a randomized, crossover and triple-blind study.

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

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

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

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

It started in 2015-09 with completion listed for 2016-11.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 8 secondary outcomes, for example AUClis_0-6h, Cmax, tCmax, BGmax, tBGmax and Compatibility.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Lispro in 80 people.

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

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