An Euglycemic Clamp Trial to Evaluate Pharmacokinetics of Single Doses of BioChaperone Insulin Lispro in Healthy Japanese Subjects

What Was Tested

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

This is a double-blind, randomised, three period crossover phase 1 trial using automated 8-hour euglycemic clamps in healthy Japanese subjects.

The total trial maximum duration for a subject will be up to 10 weeks.

It had four arms (groups): one (experimental), one (experimental), one (experimental) and Humalog® (active comparator).

The registry classes the interventions as drug.

Who Took Part

15 actual participants took part.

It was open to people of any sex aged from 20 years up to 64 years.

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

Examples of who could join: Healthy Japanese male or female subjects by completion of medical history, physical examination and biochemical investigations as judged by the Investigator. BMI between 18.5 and 25.0 kg∙m-2, both inclusive. Signed and dated informed consent obtained before any trial-related activities.

The full record lists 4 inclusion and 4 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; history of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.

How the Study Was Run

Design: randomized, crossover and quadruple-blind.

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

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

As a double-blind Insulin Lispro study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2016-01 with completion listed for 2016-05.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: AUCLispro(0-30min) (time frame: Up to 30 minutes).

It also tracked 2 secondary outcomes, for example AUCGIR(0-last) and Adverse Events.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Lispro in 15 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.