A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous NNC0143-0406 A [amount hidden]/L 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): NNC0143-0406 (experimental) and Insulin Aspart (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 48 actual participants took part.

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

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

Examples of who could join: Male, aged 18-55 years (both inclusive) at the time of signing informed consent. Subjects diagnosed (clinically) with type 1 diabetes mellitus at least 365 days prior to the day of screening. Body mass index between 18.5 and 28.0 kg/m\^2 (both inclusive).

The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: known or suspected hypersensitivity to trial product(s) or related products.

How the Study Was Run

Design: 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.

Neither the participants nor the staff measuring them knew who was on Insulin Aspart, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2015-11 with completion listed for 2016-06.

It ran at 1 site in Austria.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: The number of treatment emergent adverse events.

It also tracked 3 secondary outcomes, for example Area under the serum NNC0143-0406 concentration-time curve, Area under the glucose infusion rate-time curve and The maximum glucose infusion rate.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Aspart in 48 people.

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.