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

What Was Tested

The trial (phase 1) is built around Semaglutide.

This study will look at a new medicine, called IcoSema, for treatment of type 2 diabetes.

IcoSema is a combination of a new insulin, called insulin icodec, and a GLP-1 receptor analogue, called semaglutide.

Insulin icodec is a possible new medicine.

It had six arms (groups): Sequence 1 (experimental), Sequence 2 (experimental), Sequence 3 (experimental), Sequence 4 (experimental) and Sequence 5 (experimental).

All participants will get each of the 3 medicines at 3 different timepoints IcoSema - insulin icodec - semaglutide, separated by a 1-4-week wash-out period. The study will last for about 19 to 26 weeks.

All participants will get each of the 3 medicines at 3 different timepoints IcoSema- semaglutide . insulin icodec, separated by a 1-4-week wash-out period. The study will last for about 19 to 26 weeks.

All participants will get each of the 3 medicines at 3 different timepoints insulin icodec- IcoSema- semaglutide, separated by a 1-4-week wash-out period. The study will last for about 19 to 26 weeks.

The registry classes the interventions as drug.

Who Took Part

The registry lists 20 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: Chinese male or female. Aged 18-64 years (both inclusive) at the time of signing informed consent. Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days prior to the day of screening. Body mass index between 18.5 and 34.9 kg/m\^2 (both inclusive). Body weight greater than or equal to 50 kg.

The full record lists 13 inclusion and 4 exclusion criteria; among the exclusions: known or suspected hypersensitivity to trial product(s) or related products.

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.

Neither the participants nor the staff measuring them knew who was on Semaglutide, so expectations could not easily colour the readings.

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

It started in 2022-06-22 with completion listed for 2023-04-25.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 9 secondary outcomes, for example Adverse events.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Semaglutide in 20 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.