A Trial Investigating the Total Exposure of NN5401 (Insulin Degludec/Insulin Aspart) in Children, Adolescents and Adult Subjects With Type 1 Diabetes

What Was Tested

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

This trial was conducted in Europe.

The aim of this study was to investigate the total exposure of NN5401 (insulin degludec/insulin aspart) in children, adolescents and adult subjects with type 1 diabetes.

It had 1 arm (groups): NN5401 (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 38 actual participants took part.

It was open to people of any sex aged from 6 years up to 65 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 for children: 15.0-20.0 kg/m\^2 (both inclusive), for adolescents: 18.0-28.0 kg/m\^2 (both inclusive) and for adults maximum 30.0 kg/m\^2.

The full record lists 2 inclusion and 3 exclusion criteria; among the exclusions: not able or willing to refrain from smoking during the inpatient period; female of childbearing potential who is pregnant, breast-feeding or intends to become pregnant or is not using adequate contraceptive methods.

How the Study Was Run

Design: non-randomized, parallel-group and open-label.

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

Everyone knew when Insulin Aspart was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2010-06 with completion listed for 2010-11.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Area under the serum insulin degludec concentration-time curve. Area under the serum insulin aspart concentration-time curve.

It also tracked 2 secondary outcomes, for example Maximum observed insulin degludec concentration of NN5401 (insulin degludec/insulin aspart) observed and Maximum observed insulin aspart concentration of NN5401 (insulin degludec/insulin aspart) observed.

What This Means in Plain Language

Put simply, this is a phase 1, non-randomized trial of Insulin Aspart in 38 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.