A Study to Look at How Safe NNC0268-0965 is in Healthy People and People With Type 1 Diabetes

What Was Tested

This registered phase 1 trial tested Insulin Glargine.

This study is investigating the safety and tolerability of the new medicine NNC0268-0965 (referred to as insulin 965), its concentrations in the blood and its effect on blood sugar for the treatment of diabetes.

This first part of the study is conducted in healthy people, while there is a second part involving people with type 1 diabetes.

The study will test how insulin 965 is tolerated by the participants' body, how it is taken up in the participants' blood, how long it stays there and how blood sugar is lowered.

It had four arms (groups): Part 1 (healthy): NNC0268-0965 (experimental), Part 1 (healthy): placebo (placebo comparator), Part 2 (type 1 diabetes): NNC0268-0965 (experimental) and Part 2 (type 1 diabetes): insulin glargine (active comparator).

The registry classes the interventions as drug.

Who Took Part

78 actual participants took part.

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

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

Examples of who could join: Part 1 (healthy subjects):. Part 2 (subjects with type 1 diabetes mellitus):. Male or female, aged 18-55 years (both inclusive) at the time of signing informed consent. Diagnosed with type 1 diabetes mellitus equal to or more than1 year prior to the day of screening.

The full record lists 8 inclusion and 1 exclusion criteria.

How the Study Was Run

Design: 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.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Insulin Glargine 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 2019-06-05 with completion listed for 2019-12-14.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of treatment-emergent adverse events (time frame: From trial product administration at day 1 until completion of post-treatment end-of-trial visit at day 10).

It also tracked 3 secondary outcomes, for example Number of treatment-emergent hypoglycaemic episodes.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Glargine in 78 people.

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.