A Research Study to Look at How Insulin 287 and Semaglutide Work in the Body of People With Type 2 Diabetes When Taken Alone or Together

What Was Tested

This registered phase 1 trial tested Semaglutide.

The study will look at how insulin 287 and semaglutide work in the body, both when given alone or together.

This study will look at the way insulin 287 and semaglutide reach and stay in participants' blood after injection when given alone or together.

Participants will get 3 study medicines at 3 different time points: 1) a combination of semaglutide plus insulin 287, 2) insulin 287 alone and 3) semaglutide alone.

It had three arms (groups): Semaglutide plus insulin 287 (experimental), Semaglutide alone (experimental) and Insulin 287 alone (experimental).

The registry classes the interventions as drug.

Who Took Part

30 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 more than or equal to 180 days prior to the day of screening. Body weight between 80.0 to 120.0 kg (both inclusive).

The full record lists 6 inclusion and 5 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 adequate contraceptive methods; receipt of any investigational medicinal product within 90 days before screening.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Semaglutide and who got the comparison, which limits bias.

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

As a double-blind Semaglutide 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 2019-01-17 with completion listed for 2019-10-10.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 20 secondary outcomes, for example Number of treatment emergent adverse events, Number of hypoglycaemic episodes, Antibodies for insulin 287: Change in anti-insulin 287 binding antibody levels, Antibodies for insulin 287: Occurrence of anti-insulin 287 binding antibodies, Antibodies for insulin 287: Occurrence of anti-insulin 287 binding antibodies cross reacting to human insulin and Antibodies for semaglutide: Change in anti-semaglutide binding antibody levels.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Semaglutide in 30 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 Semaglutide compound page, all human trials.