Pharmacokinetics of Biphasic Insulin Aspart 50 and 70 in Japanese Healthy Volunteers

What Was Tested

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

This trial is conducted in Japan.

It had two arms (groups): Treatment period 1 (experimental) and Treatment period 2 (experimental).

The registry classes the interventions as drug.

Who Took Part

24 actual participants took part.

It was open to men only aged from 20 years up to 40 years.

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

Examples of who could join: Body Mass Index (BMI) of 19-27 kg/m\^2 (both inclusive). Considered generally healthy upon completion of medical history and physical examination, as judged by the Investigator or Sub-Investigator.

The full record lists 5 inclusion and 13 exclusion criteria; among the exclusions: any serious systemic infectious disease that occurred during the 4 weeks prior to the screening, as judged by the investigator or sub-investigator; any inter-current illness that may affect blood glucose, as judged by the investigator or sub-investigator; hepatitis b or c, or hiv (human immunodeficiency virus).

How the Study Was Run

Design: randomized, crossover and open-label.

Random assignment meant chance, not the researchers, decided who got Insulin Aspart and who got the comparison, which limits bias.

Each person switched between Insulin Aspart and the comparison at some point, usually with a gap in between.

Being open-label, the Insulin Aspart study did not mask who received what.

It started in 2000-02 with completion listed for 2000-04.

It ran at 1 site in Japan.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Area under the insulin aspart curve in the interval from 0 to 24 hours (BIAsp 70).

It also tracked 7 secondary outcomes, for example Cmax, maximum insulin aspart concentration, tmax, time to maximum insulin aspart concentration, t½, terminal elimination half life, Mean residence time (MRT), Area under the curve from time 0 to infinity (0-∞) and Area under the insulin aspart curve in the interval from 0 to 24 hours (BIAsp 50).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Aspart in 24 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.