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

What Was Tested

This registered phase 1 trial tested Insulin Aspart.

This trial is conducted in Africa.

The aim of this trial is to investigate the bioequivalence of two formulations of biphasic insulin aspart 50 in healthy male 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 18 years up to 55 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. Body Mass Index (BMI) between 19-29 kg/m\^2 (both inclusive). Minimum body weight of 65 kg.

The full record lists 6 inclusion and 7 exclusion criteria; among the exclusions: history of or current addiction to alcohol or drugs of abuse as determined by the investigator (positive drug/alcohol abuse screen); hepatitis b or c; subjects with a first-degree relative with diabetes mellitus.

How the Study Was Run

Design: randomized, crossover and double-blind.

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

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 2002-11-05 with completion listed for 2002-12-18.

It ran at 1 site in South Africa.

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 0-16 hours. Cmax, maximum insulin aspart concentration.

It also tracked 7 secondary outcomes, for example tmax, the time to maximum insulin aspart concentration, Area under the insulin aspart curve, Mean residence time (MRT), The area under the glucose infusion rate curve, GIRmax, maximum glucose infusion rate value and tGIRmax, time to maximum glucose infusion rate value.

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.