A Study to Look at How Safe Insulin NNC0471-0119 is and How it Works in People With Type 1 Diabetes Mellitus

What Was Tested

The trial (phase 1) is built around Insulin Aspart.

This study is looking at the safety of the new medicine, insulin NNC0471-0119, its concentrations in the blood and effect on blood sugar for the treatment of type 1 diabetes.

Insulin NNC0471-0119 will be compared to faster aspart.

The purpose of this study is to test how insulin NNC0471-0119 is tolerated by participants body, how it is transported in participants bloodstream, how long it stays there and how the blood sugar is lowered compared to faster aspart.

It had two arms (groups): NNC0471-0119 (experimental) and Faster aspart (active comparator).

Participants randomised to NNC0471-0119.

Participants randomised to faster aspart.

The registry classes the interventions as drug.

Who Took Part

The registry lists 48 actual participants took part.

It was open to people of any sex aged from 18 years up to 55 years.

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

Examples of who could join: Aged 18-55 years (both inclusive) at the time of signing informed consent. Diagnosed with Type 1 Diabetes Mellitus (T1DM) greater than or equal to 1 year prior to the day of screening.

The full record lists 4 inclusion and 2 exclusion criteria; among the exclusions: known or suspected hypersensitivity to investigational medicinal products (imps) or related products; participation in any clinical trial of an approved or non-approved imp within 90 days before screening.

How the Study Was Run

Design: randomized, parallel-group and quadruple-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.

Blinding on both sides kept the participants and researchers unaware of who received Insulin Aspart.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2020-11-09 with completion listed for 2021-11-26.

It ran at 1 site in Austria.

Its stated primary purpose is treatment.

What Was Measured

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

It also tracked 7 secondary outcomes, for example Number of hypoglycaemic episodes, Cmax,NNC0471-0119: Maximum observed serum NNC0471- 0119 concentration, tmax,NNC0471-0119: Time to maximum observed serum NNC0471-0119 concentration and t½, NNC0471-0119: Terminal half-life for NNC0471-0119.

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.