A Randomised Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of Faster-acting 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 two arms (groups): Faster-acting insulin aspart (experimental) and NovoRapid® (active comparator).

Each subject will be allocated to two treatments (in random sequence).

Each subject will be allocated to two treatments (in random sequence).

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: Male or female 18-64 years (both inclusive) at the time of signing informed consent. Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months. Body mass index 18.5-28.0 kg/m\^2 (both inclusive).

The full record lists 3 inclusion and 2 exclusion criteria; among the exclusions: smoker (defined as a subject who is smoking at least one cigarette, cigar or pipe daily).

How the Study Was Run

It was run as a randomized, crossover and open-label study.

The participants were allocated by chance, so the Insulin Aspart group and the comparison group should start out alike.

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

Being open-label, the Insulin Aspart study did not mask who received what.

It started in 2014-05 with completion listed for 2014-07.

It ran at 1 site in Austria.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Mean plasma glucose concentration (time frame: From 0-6 hours after start of a standardised meal).

It also tracked 1 secondary outcome, for example Area under the serum insulin aspart 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.