PK/PD Study of Gan & Lee Insulin Aspart Injection vs. US & EU NovoLog®/NovoRapid® in Healthy Males

What Was Tested

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

It had three arms (groups): Gan & Lee Insulin Aspart (experimental), NovoRapid® Insulin Aspart (active comparator) and NovoLog® Insulin Aspart (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 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, physical examination, vital signs, ECG and analysis of laboratory safety variables, as judged by the Investigator.

The full record lists 6 inclusion and 9 exclusion criteria; among the exclusions: known or suspected hypersensitivity to investigational medicinal products (imps) or related product; previous participation in this trial. participation is defined as randomized; history of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.

How the Study Was Run

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

Because people in this Insulin Aspart 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 Aspart and the comparison in turn, acting as their own control.

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

Those kept unaware of assignments: participant and investigator.

It started in 2019-08-27 with completion listed for 2019-12-16.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: AUCins.0-12h (time frame: 0 -12 hours). Cins.max (time frame: 0 -12 hours). AUCGIR.0-12h (time frame: 0 - 12 hours).

It also tracked 13 secondary outcomes, for example AUCins.0-2h, AUCins.0-∞, tins.max, t½, λz and AUCGIR.0-2h.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Aspart 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 Aspart compound page, all human trials.