Pharmacokinetics and Pharmacodynamics of Biphasic Insulin Aspart 30 in Healthy Volunteers

What Was Tested

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

This trial is conducted in Europe.

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

The registry classes the interventions as drug.

Who Took Part

24 actual participants took part.

It was open to men only aged from 18 years up to 50 years.

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

Examples of who could join: BMI (body mass index) maximum 27 kg/m\^2.

The full record lists 4 inclusion and 0 exclusion criteria.

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.

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 1995-11 with completion listed for 1995-12.

It ran at 1 site in United Kingdom.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Area under the Curve.

It also tracked 5 secondary outcomes, for example Maximum insulin concentration (Cmax), Time to maximum insulin concentration (tmax), Minimum glucose concentration (Cmin(glu)), Time to minimum glucose concentration (tmin(glu)) and Adverse events.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Aspart in 24 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.