Study to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity Between NKF-INS(L), US-Humalog®, and EU-Humalog®

What Was Tested

This registered phase 1 trial tested Insulin Lispro.

It had three arms (groups): NKF-INS Lispro (L) (experimental), United States (US)-Humalog® (active comparator) and European Union (EU)-Humalog® (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 54 actual participants took part.

It was open to men only aged from 18 years up to 50 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 participant. Healthy male participants. Age between 18 and 50 years, both inclusive. Body Mass Index between 18.5 and 29.0 kg/m2, both inclusive. Body weight ≥ 50 kg.

The full record lists 10 inclusion and 19 exclusion criteria; among the exclusions: positive for human insulin antibodies at screening; history of diabetes mellitus; episodes of hypoglycemia in the anamnesis; any history of insulin use for treatment purposes; show evidence of an acute infection with fever or infectious disease at the time of enrollment.

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.

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 and investigator.

It started in 2025-10-13 with completion listed for 2026-03-02.

It ran at 1 site in South Africa.

Its stated primary purpose is other.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Lispro in 54 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.