Comparison of Two Formulations of Biphasic Insulin Aspart 70

What Was Tested

This registered phase 1 trial tested Insulin Aspart.

This trial is conducted in Europe.

It had three arms (groups): BIAsp 70 clinical trial formulation (experimental), BIAsp 70 final formulation (experimental) and BIAsp 50 final formulation (experimental).

The registry classes the interventions as drug.

More on the Plan

Each subject participated in three treatment periods, and were randomly assigned to each of the six treatment sequences in varying order.

Who Took Part

24 actual participants took part.

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

Healthy volunteers were not accepted; participants needed the condition being studied.

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 19-27 kg/m\^2.

The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: participation in any other clinical trial involving other investigational products within the last three months.

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.

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 1999-11-03 with completion listed for 1999-11-30.

It ran at 1 site in United Kingdom.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Area under the insulin aspart curve in the interval from 0-24 hours.

It also tracked 5 secondary outcomes, for example Cmax, maximum insulin aspart concentration, tmax, the time to maximum insulin aspart concentration, t½, terminal half-life, Cmin, minimum glucose concentration and tmin, time to minimum concentration.

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.