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

What Was Tested

The trial (phase 1) is built around 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: Considered generally healthy upon completion of medical history and physical examination, as judged by the Investigator or Sub-Investigator. Body Mass Index (BMI) between 19-29 kg/m\^2 (inclusive).

The full record lists 3 inclusion and 9 exclusion criteria; among the exclusions: any serious systemic infectious disease that had occurred during the 4 weeks prior to the screening, as judged by the investigator or sub-investigator; any inter-current illness that might affect blood glucose, as judged by the investigator or sub-investigator; hepatitis b or c, or hiv (human immunodeficiency virus) positive.

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 Aspart group and the comparison group should start out alike.

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 2002-11-16 with completion listed for 2003-01-08.

It ran at 1 site in Japan.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Area under the insulin aspart concentration-time curve in the interval from 0 to 16 hours. Cmax, maximum insulin aspart concentration.

It also tracked 4 secondary outcomes, for example Area under the insulin aspart concentration-time curve, Tmax, time to maximum insulin aspart concentration, MRT, mean residence time and t½, terminal half-life.

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.