A Clinical Trial Investigating the Intra-subject Variability of Pharmacokinetics and Glucodynamics of BioChaperone Insulin Lispro U-100 Product and U-200 Product in Healthy Volunteers

What Was Tested

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

This is a double-blinded, randomised, single-centre phase I pilot trial for exploring the feasibility of a pivotal clinical trial establishing bioequivalence between BioChaperone insulin lispro U-200 and BioChaperone insulin lispro U-100 in healthy subjects.

It had two arms (groups): BioChaperone Lispro U-100 (active comparator) and BioChaperone Lispro U-200 (experimental).

The registry classes the interventions as drug.

Who Took Part

26 actual participants took part.

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

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Male or female subjects, considered generally healthy upon completion of medical history, physical examination and biochemical investigations as judged by the Investigator. Age ≥ 18 and ≤ 64 years, both inclusive. Body Mass Index (BMI) between 18.5 and 28.0 kg∙m-2, both inclusive. Signed and dated informed consent obtained before any trial-related activities, i.e. any procedures that would not have been performed during normal management of the subject).

The full record lists 5 inclusion and 2 exclusion criteria; among the exclusions: known or suspected hypersensitivity to trial product(s) or related products; receipt of any investigational medicinal product within 3 months before randomisation in this trial.

How the Study Was Run

Design: randomized, crossover and triple-blind.

Because people in this Insulin Lispro study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

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 2015-08 with completion listed for 2015-11.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: AUCLisp (0-inf) (time frame: 8 hours). Cmax Lisp (time frame: 8 hours).

It also tracked 6 secondary outcomes, for example tmax Lisp, AUCGIR(0-8h), GIRmax, tGIRmax, Number of Adverse events and Local tolerability.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Lispro in 26 people.

Its size is small, so on its own it can only give an early look.

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.