Study to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity Between NKF-INS(A), US-NovoLog®, and EU-NovoRapid®

What Was Tested

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

It had three arms (groups): NKF-INS(A) (experimental), EU-NovoRapid® (active comparator) and US-NovoLog® (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 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 17 exclusion criteria; among the exclusions: positive for human insulin antibodies at screening; have known allergies to insulin, its excipients, or related drugs or have history of relevant allergic reactions of any origin; history of diabetes mellitus; episodes of hypoglycemia in the anamnesis; any history of insulin use for treatment purposes.

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.

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

Those kept unaware of assignments: participant and investigator.

It started in 2024-07-30 with completion listed for 2024-10-31.

It ran at 1 site in South Africa.

Its stated primary purpose is other.

What Was Measured

Researchers chose this as the main measure: Aspart Concentration-time Curve From 0 to 12 Hours Area Under the Insulin Aspart Concentration-Time Curve (AUC0-t) (time frame: Day 1 for 12 Hours). Maximum Observed Insulin Aspart Concentration Maximum Observed Insulin Aspart Concentration (Cmax) (time frame: Day 1 for 12 Hours). Area Under the GIR-time Curve From 0 to 12 Hours (AUCGIR0-t) (time frame: Day 1 for 12 Hours).

It also tracked 6 secondary outcomes, for example The Terminal Elimination Half-life (t1/2) and PK Parameters for Serum Insulin Aspart Concentrations: Area Under the Insulin Aspart Concentration-Time Curve AUC6-12h.

What This Means in Plain Language

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

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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