Comparison of the Pharmacodynamics and Pharmacokinetics of Biphasic Insulin Aspart 30, 50, 70 and Insulin Aspart in Subjects With Type 1 Diabetes

What Was Tested

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

This trial is conducted in Europe.

It had four arms (groups): BIAsp 30 (active comparator), BIAsp 50 (experimental), BIAsp 70 (experimental) and IAsp (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 32 actual participants took part.

It was open to people of any sex aged from 18 years up to 55 years.

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

Examples of who could join: Type 1 diabetes for at least 12 months. Serum C-peptide maximum 0.4 ng/mL. Current basal bolus treatment with soluble human insulin, insulin lispro, insulin glulisine, NPH insulin, insulin detemir or insulin glargine. BMI (Body Mass Index) maximum 32 kg/m\^2.

The full record lists 6 inclusion and 8 exclusion criteria; among the exclusions: the receipt of any investigational drug within the last 30 days prior to this trial; current treatment with iasp (insulin aspart) products; A history of drug or alcohol abuse within the last 5 years.

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.

As a double-blind Insulin Aspart study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2006-04 with completion listed for 2006-07.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 11 secondary outcomes, for example Maximum GIR value, Time to maximum GIR value, Area under the GIR-curves, Maximum drug concentration for insulin aspart (IAsp), Time to maximum IAsp concentration and Area under the curve of the IAsp profiles.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Aspart in 32 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.