Safety, Tolerability and Pharmacokinetic and Pharmacodynamic Characteristics of Explorative Formulations of Insulin Degludec and IDegAsp 50 in Healthy Japanese Subjects

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): one (experimental), one (experimental), one (experimental) and IDegAsp 50 (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 32 actual participants took part.

It was open to men only aged from 18 years up to 55 years.

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

Examples of who could join: Japanese passport holder. Body mass index (BMI) between 18.0 and 27.0 kg/m\^2 (both inclusive).

The full record lists 5 inclusion and 2 exclusion criteria; among the exclusions: the receipt of any investigational drug within 3 months prior to this trial.

How the Study Was Run

The set-up was randomized, parallel-group 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.

The Insulin Aspart group and the comparison group ran side by side rather than switching.

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 2006-12 with completion listed for 2007-03.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Frequency of adverse events (AEs).

It also tracked 2 secondary outcomes, for example Area under the serum insulin concentration curve and Area under the glucose infusion rate curve.

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.