A Research Study of How Overdosing of a New Once Weekly Medicine NNC0148-0287 C (Insulin 287) Influences the Blood Sugar Level in People With Type 2 Diabetes

What Was Tested

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

This study is comparing the effect of a long-acting insulin analogue (insulin 287) with insulin glargine (Lantus®) in subjects with type 2 diabetes.

The purpose of the study is to make a once-weekly injectable basal insulin treatment for people with type 2 diabetes.

It had two arms (groups): Insulin 287 followed by insulin glargine (experimental) and Insulin glargine followed by insulin 287 (active comparator).

Run-in period (3 to 28 days): Once daily insulin glargine treatment with or without any usual metformin treatment. After run-in, participants will receive insulin 287 once a week (OW) for 6 weeks. After insulin 287 treatment, participants will receive insulin glargine U100 OD for 12 days.

Run-in period (3 to 28 days): Once daily insulin glargine treatment with or without any usual metformin treatment. After run-in, participants will receive insulin glargine U100 OD for 12 days. After insulin glargine treatment, participants will receive insulin 287 OW for 6 weeks.

The registry classes the interventions as drug.

Who Took Part

43 actual participants took part.

It was open to people of any sex aged from 18 years up to 72 years.

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

Examples of who could join: Male or female, aged between 18 and 72 years (both inclusive) at the time of signing informed consent. Body mass index between 18.5 and 37.9 kg/m\^2 (both inclusive). Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days prior to the day of screening.

The full record lists 5 inclusion and 3 exclusion criteria; among the exclusions: known or suspected hypersensitivity to trial products or related products; female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method.

How the Study Was Run

The set-up was randomized, crossover and open-label.

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

Each person switched between Insulin Glargine and the comparison at some point, usually with a gap in between.

Being open-label, the Insulin Glargine study did not mask who received what.

It started in 2019-05-07 with completion listed for 2021-09-27.

It ran at 1 site in Austria.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Glargine in 43 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.