A Research Study of How Different Amounts of a New Medicine NNC0148-0287 C (Insulin 287) Works on the Blood Sugar of People Who Are Japanese With Type 1 Diabetes When Given Once a Week

What Was Tested

This registered phase 1 trial tested Insulin Glargine.

The study will test how insulin goes through your blood, how long it stays there and how the blood sugar is lowered.

Insulin 287 is a new medicine.

It had two arms (groups): Insulin 287 followed by insulin glargine U100 (experimental) and Insulin glargine U100 followed by insulin 287 (experimental).

The registry classes the interventions as drug.

Who Took Part

24 actual participants took part.

It was open to people of any sex aged from 20 years up to 64 years.

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

Examples of who could join: Male or female, Japanese subjects, aged 20 - 64 years (both inclusive) at the time of signing informed consent. Diagnosed with type 1 diabetes mellitus greater than or equal to 1 year prior to the day of screening. Body mass index between 18.5 and 28.0 kg/m\^2 (both inclusive).

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

How the Study Was Run

Design: randomized, crossover and open-label.

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.

In the crossover set-up each of the participants took both Insulin Glargine and the comparison in turn, acting as their own control.

Nothing was hidden in this open-label Insulin Glargine study: the participants and staff both knew the treatment.

It started in 2018-12-07 with completion listed for 2019-12-09.

It ran at 1 site in Japan.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 22 secondary outcomes, for example Number of adverse events (AEs), Number of hypoglycaemic episodes, Change in antiinsulin 287 antibody level, Change in antiinsulin 287 antibody titres, Positive cross-reactive anti-human insulin antibodies and t1/2,I287,SS - Terminal half-life for insulin 287 at steady state.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Glargine in 24 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.