A Study to Look at How Safe NNC0268-0965 is in People With Type 2 Diabetes

What Was Tested

This registered phase 1 trial tested Insulin Glargine.

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

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

Participants will either get the new insulin 965 or the already marketed insulin glargine U100 (Lantus®) - which treatment is decided by chance.

It had two arms (groups): NNC0268-0965 (experimental) and Insulin glargine (active comparator).

Participants will receive NNC0268-0965.

Participants will receive insulin glargine.

The registry classes the interventions as drug.

Who Took Part

The registry lists 36 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: Male or female, aged 18-64 years (both inclusive) at the time of signing informed consent. Diagnosed with type 2 diabetes mellitus 180 days or more prior to the day of screening.

The full record lists 5 inclusion and 2 exclusion criteria; among the exclusions: use of glp-1 receptor agonists (e.g. exenatide, liraglutide, semaglutide) within 3 months prior to screening.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

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

The Insulin Glargine 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 Glargine, so expectations could not easily colour the readings.

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

It started in 2019-10-29 with completion listed for 2020-08-23.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Number of treatment-emergent adverse events (AEs) (time frame: From IMP administration at day 1 (visit 2) until completion of post-treatment end-of-trial visit at day 12 (visit 5)).

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 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.