PK/PD Biosimilarity Study of Gan & Lee Insulin Lispro Injection vs. EU and US Humalog® in Healthy Males

What Was Tested

This registered phase 1 trial tested Insulin Lispro.

It had three arms (groups): Gan & Lee Insulin Lispro Injection (experimental), EU - approved Humalog ® (active comparator) and US - licensed Humalog ® (active comparator).

The registry classes the interventions as drug.

Who Took Part

36 actual participants took part.

It was open to men only aged from 18 years up to 64 years.

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

Examples of who could join: Signed and dated informed consent obtained before any trial related activities. Trial related activities are any procedures that would not have been done during normal management of the subject. Healthy male subjects. Age between 18 and 64 years, both inclusive. Body Mass Index (BMI) between 18.5 and 29.0 kg/m\^2, both inclusive. Considered generally healthy upon completion of medical history and screening safety assessments, as judged by the Investigator.

The full record lists 6 inclusion and 26 exclusion criteria; among the exclusions: known or suspected hypersensitivity to imp(s) or related product; previous participation in this trial. participation is defined as randomized; receipt of any medicinal product in clinical development within 30 days before randomization in this trial.

How the Study Was Run

Design: randomized, crossover and double-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.

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 and investigator.

It started in 2019-04-23 with completion listed for 2019-07-03.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): AUCins.0-12h (time frame: 0 to 12 hours). Cins.max (time frame: 0 to 12 hours). AUCGIR.0-12h (time frame: 0 to 12 hours).

It also tracked 19 secondary outcomes, for example AUCins.0-2h, AUCins.0-4h, AUCins.0-6h, AUCins.6-12h, AUCins.0-∞ and tins.max.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Lispro in 36 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.