Pharmacokinetics, Pharmacodynamics and Safety of Biphasic Insulin Aspart 30 in Type 2 Diabetes

What Was Tested

This registered phase 2 trial tested Insulin Aspart.

This trial is conducted in Europe.

It had two arms (groups): BIAsp 30 (experimental) and BHI 30 (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 13 actual participants took part.

It was open to people of any sex aged from 40 years up to 75 years.

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

Examples of who could join: Type 2 diabetes for at least 12 months. Treated with a combination of soluble/protracted human insulin in the ratio of 30/70 in a twice-daily regimen for at least 6 months. BMI (body mass index) below 39 kg/m\^2.

The full record lists 4 inclusion and 0 exclusion criteria.

How the Study Was Run

Design: randomized, crossover and double-blind.

Because people in this Insulin Aspart study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

In the crossover set-up each of the participants took both Insulin Aspart and the comparison in turn, acting as their own control.

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 1997-04 with completion listed for 1998-11.

It ran at 2 sites in Netherlands (1) and United Kingdom (1).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Area under the serum insulin curve.

It also tracked 6 secondary outcomes, for example Overall shape of the 24 hour serum insulin profile, Cmax (maximum plasma concentration), tmax (time to reach maximum), Area under the curve following each injections derived from 24 hours serum insulin profiles, Overall shape of the 24 hour serum glucose profile and Serum glucose excursions (EXC).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin Aspart in 13 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.