Study to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity Between NKF-INS Glargine (G), United States (US)-Lantus®, and European Union (EU)-Lantus®

What Was Tested

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

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

The registry classes the interventions as drug.

Who Took Part

114 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 ≥ 59 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

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

The participants were allocated by chance, so the Insulin Glargine group and the comparison group should start out alike.

In the crossover set-up each of the participants took both Insulin Glargine and the comparison in turn, acting as their own control.

Blinding on both sides kept the participants and researchers unaware of who received Insulin Glargine.

Those kept unaware of assignments: participant and investigator.

It started in 2024-10-29 with completion listed for 2025-07-03.

It ran at 1 site in South Africa.

Its stated primary purpose is other.

What Was Measured

The main thing measured (primary outcome): Area Under the M1 Concentration-Time Curve From 0 to 12 Hours (AUC0-12h of M1).

It also tracked 23 secondary outcomes, for example Maximum Capacity (Cmax) of M1, Area Under the Concentration-Time Curve AUC0-6h, AUC6-12h and AUC0-12h of M1, Area Under the Concentration-Time Curve AUC12-18h and AUC12-24h of M1, Area Under the Concentration-Time Curve AUC18-24h of M1, Time to Maximum Concentration (Tmax) of M1 and Area Under the Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-∞) of M1.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Glargine in 114 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Glargine compound page, all human trials.