A Multiple Dose Study Investigating Pharmacokinetics and Pharmacodynamics of Subcutaneous NNC0363-0845 in Participants With Type 1 Diabetes Pharmacokinetics and Pharmacodynamics: How Insulin NNC0363-0845 is Transported Throughout the Body and How It Works

What Was Tested

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

This study is designed to investigate the movement of insulin NNC0363-0845 throughout the body and how it works for the treatment of type 1 diabetes mellitus.

Participants will get insulin NNC0363-0845 as well as insulin detemir (Levemir®).

It had two arms (groups): NNC0363-0845 followed by insulin detemir (experimental) and Insulin detemir followed by NNC0363-0845 (experimental).

Participants will get subcutaneous (under the skin) injections of insulin NNC0363-0845 (study medicine) up to 6 times daily for 3 days. After a 4-21 days wash-out period with no injections they will get subcutaneous injections of insulin detemir up to 6 times daily for 3 days.

Participants will get subcutaneous (under the skin) injections of insulin detemir up to 6 times daily for 3 days. After a 4-21 days wash-out period with no injections they will get subcutaneous injections of NNC0363-0845 (study medicine) up to 6 times daily for 3 days.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 30 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: Aged 18-64 years (both inclusive) at the time of signing informed consent. Diagnosed with type 1 diabetes mellitus 1 year or more before screening. Body mass index between 18.5-29.9 kg/m\^2 (both inclusive).

The full record lists 7 inclusion and 1 exclusion criteria.

How the Study Was Run

Design: randomized, crossover and quadruple-blind.

Because people in this Insulin Detemir study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

As a double-blind Insulin Detemir study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2021-12-01 with completion listed for 2022-05-06.

It ran at 1 site in Austria.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: AUCPG,0.5-2h Area under the plasma glucose-time curve at steady concentrations (time frame: From 0.5 to 2 hours after initiation of meal glucose appearance test (visit 4 day 3 and visit 5 day 3)).

It also tracked 6 secondary outcomes, for example AUCPG,0-1h Area under the plasma glucose-time curve at steady concentrations, AUCPG,0-2hArea under the plasma glucose-time curve at steady concentrations, AUCPG,0-4h Area under the plasma glucose-time curve at steady concentrations, ∆PGav,0-1h Mean change in plasma glucose at steady concentrations, ∆PGav,0-2h Mean change in plasma glucose at steady concentrations and Number of adverse events.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Detemir in 30 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 Detemir compound page, all human trials.