A Trial Investigating the Pharmacodynamic and Pharmacokinetic Properties of Insulin Degludec/Insulin Aspart 15 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 five arms (groups): IDegAsp 15 (experimental), IDegAsp (experimental), IDeg (experimental), IAsp (active comparator) and IDeg + IAsp (experimental).

The registry classes the interventions as drug.

Who Took Part

33 actual participants took part.

It was open to people of any sex aged from 18 years up to 64 years.

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

Examples of who could join: Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months. Body mass index 18.0-28.0 kg/m\^2 (both inclusive).

The full record lists 2 inclusion and 4 exclusion criteria; among the exclusions: smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day); not able or willing to refrain from smoking, use of nicotine substitute products or transdermal nicotine patches during the inpatient period.

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.

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 2013-01 with completion listed for 2013-08.

It ran at 1 site in Austria.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Area under the glucose infusion rate curve.

It also tracked 2 secondary outcomes, for example Area under the serum IDeg concentration-time curve and Area under the serum IAsp concentration-time curve.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Aspart in 33 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.