Bioequivalence of Two Formulations of Biphasic Insulin Aspart 70 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 70 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

40 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 9 exclusion criteria; among the exclusions: 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); HIV (human immunodeficiency virus), Hepatitis B or C 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.

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

As a double-blind Insulin Aspart study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2003-12 with completion listed for 2004-02.

It ran at 1 site in Germany.

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 Incidence of hypoglycaemic events.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Aspart in 40 people.

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.