A Clinical Study to Compare the Efficacy and Safety of a Novel Medicine (NNC0268-0965) With Insulin Glargine

What Was Tested

This registered phase 1 trial tested Insulin Glargine.

The study aims to show that insulin 965 has positive effects on the blood vessels.

Participants will get either the new insulin 965 or insulin glargine - a medicine that doctors already can prescribe (Lantus®).

It had two arms (groups): NNC0286-0965 (experimental) and Insulin glargine (active comparator).

NNC0286-0965 administered together with insulin glargine placebo. If previously treated with oral anti-diabetic drugs (OADs), participants will remain on these in the trial.

Insulin glargine administered together with NNC0286-0965 placebo. If previously treated with OADs, participants will remain on these in the trial.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 86 actual participants took part.

It was open to people of any sex aged from 40 years up to 75 years.

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

Examples of who could join: Aged 40-75 years (both inclusive) at the time of signing informed consent. Diagnosed with diabetes mellitus, type 2 (T2DM) at least 180 days prior to the day of screening.

The full record lists 10 inclusion and 12 exclusion criteria; among the exclusions: previous exposure to insulin 287 formulation a (i.e. trial nn1436-4057); myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 180 days to the day of screening; presently classified as being in new york heart association (nyha) class iii or iv.

How the Study Was Run

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

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 2020-10-21 with completion listed for 2021-12-10.

It ran at 2 sites in Germany (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in flow mediated dilation (time frame: From Visit 3B (week 0) to visit 30B (week 26)).

It also tracked 13 secondary outcomes, for example Change in pulse wave velocity, Change in leg blood flow, Change in retinal arteriolar dilation, Relative change in liver fat percentage measured by magnetic resonance imaging proton density fat fraction (MRI-PDFF), Change in left ventricular ejection fraction and Change in glycosylated haemoglobin (HbA1c ).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Glargine in 86 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.