Bioequivalence of Two Formulations of Biphasic Insulin Aspart 50 in Japanese Subjects

What Was Tested

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

This trial is conducted in Japan.

The aim of this trial is to investigate the bioequivalence of two formulations of biphasic insulin aspart 50 (NN-X14Mix50) in healthy Japanese subjects.

It had two arms (groups): Formulation A (experimental) and Formulation B (experimental).

The registry classes the interventions as drug.

Who Took Part

30 actual participants took part.

It was open to men only aged from 20 years up to 50 years.

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

Examples of who could join: BMI (body mass index) between 19-29 kg/m\^2 (both inclusive).

The full record lists 3 inclusion and 2 exclusion criteria; among the exclusions: subjects with a first-degree relative with diabetes mellitus; subjects smoke 5 cigarettes or more per day.

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.

Neither the participants nor the staff measuring them knew who was on Insulin Aspart, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2003-11-29 with completion listed for 2003-12-30.

It ran at 1 site in Japan.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Area under the insulin aspart curve in the interval from 0-16 hours. Cmax, maximum insulin aspart concentration.

It also tracked 5 secondary outcomes, for example tmax, time to maximum insulin aspart concentration, Area under the insulin aspart curve, Mean residence time (MRT), t½, terminal half-life and Adverse events.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Aspart in 30 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.