Comparison of Two Biphasic Insulin Aspart 30 Formulations (Current and New Formulation) in Healthy Volunteers

What Was Tested

In this phase 1 trial, researchers set out to test Insulin Aspart.

This trial is conducted in the United states of America (USA).

The aim of this trial is to compare two formulations of biphasic insulin aspart 30 in healthy volunteers.

It had two arms (groups): Formulation 1 (experimental) and Formulation 2 (active comparator).

The registry classes the interventions as drug.

Who Took Part

50 actual participants took part.

It was open to people of any sex aged from 18 years up to 45 years.

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

Examples of who could join: BMI (body mass index) between 18 and 28 kg/m\^2, both inclusive. Subject is a nonsmoker for at least 3 months. Subject is judged to be in good health on the basis of their medical history, physical examination, ECG (electrocardiogram), and routine laboratory data.

The full record lists 4 inclusion and 3 exclusion criteria.

How the Study Was Run

The set-up was 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.

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 2005-05 with completion listed for 2005-11.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Area under the concentration curve (AUC) of the two formulations from time 0 hours to infinity. Maximum drug concentration of the two formulations (Cmax).

It also tracked 3 secondary outcomes, for example Area under the concentration curve for insulin aspart from time 0 hours to 16 hours, Mean residence time (MRT) and Frequency of adverse events.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Aspart in 50 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.