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

What Was Tested

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

This trial is conducted in Europe.

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

The registry lists 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 19.0-30.0 kg/m\^2. Glycohemoglobin (HbA1c) within laboratory normal range.

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: the receipt of any investigational drug within the last 3 months prior to this trial; liver enzyme values (alat and asat) exceeding 2 times the upper reference limit according to the local laboratory; history of or current addiction to alcohol or drugs of abuse as determined by the investigator (positive urine drug screen and breath alcohol screen).

How the Study Was Run

Design: randomized, crossover and double-blind.

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 2003-11-11 with completion listed for 2003-12-17.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: 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 Incidence of hypoglycaemic 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.