Bioequivalence of Two Formulations of Biphasic Insulin Aspart 70 in Healthy Male Subjects

What Was Tested

In this phase 1 trial, researchers set out to test 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 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

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 7 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

The set-up was randomized, crossover and double-blind.

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.

Neither the participants nor the staff measuring them knew who was on Insulin Aspart, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2003-01-20 with completion listed for 2003-02-26.

It ran at 1 site in South Africa.

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 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.