A Study to Look at How Safe NNC0472-0147 is in Healthy People and in People With Type 2 Diabetes

What Was Tested

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

This study is investigating the safety and tolerability of the new medicine NNC0472-0147, its concentrations in the blood and its effect on blood sugar for the treatment of diabetes.

Another goal of the study is to determine an effect of NNC0472-0147 on cholesterol.

The first part of the study is conducted in healthy people, while the second part involves people with type 2 diabetes (T2DM).

It had four arms (groups): NNC0472-0147 Part 1 (experimental), Placebo Part 1 (placebo comparator), NNC0472-0147 Part 2 (experimental) and Insulin glargine Part 2 (active comparator).

The registry classes the interventions as drug.

Who Took Part

36 actual participants took part.

It was open to people of any sex aged from 18 years up to 64 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Aged 18-55 years (both inclusive) at the time of signing nformed consent. Aged 18-64 years (both inclusive) at the time of signing informed consent. Diagnosed with T2DM at least 180 days prior to the day of screening. Treated with any insulin for 90 days or longer prior to the day of screening.

The full record lists 7 inclusion and 3 exclusion criteria; among the exclusions: treatment with peptide proprotein convertase subtilisin/kexin type 9 (pcsk9) inhibitors within 180 days prior to the day of screening.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

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

The Insulin Glargine 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 Glargine.

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

It started in 2020-03-02 with completion listed for 2020-09-25.

It ran at 2 sites in Germany (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Part 1: Number of treatment emergent adverse events (time frame: From IMP administration at day 1 (visit 2) until completion of post-treatment end-of-trial visit (day 15, visit 6)). Part 2: Number of treatment emergent adverse events (time frame: From IMP administration at day 1 (visit 2) until completion of post-treatment end-of-trial visit (day 30, visit 14)).

It also tracked 10 secondary outcomes, for example Number of severe hypoglycaemic episodes (level 3), Number of severe hypoglycaemic episodes (level 3) and Maximum observed serum NNC0472-0147 concentration at steady state.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Glargine in 36 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 Glargine compound page, all human trials.