A Research Study to See How Well the New Weekly Medicine IcoSema, Which is a Combination of Insulin Icodec and Semaglutide, Controls Blood Sugar Level in People With Type 2 Diabetes Compared to Weekly Semaglutide (COMBINE 2)

What Was Tested

This registered phase 3 trial tested Semaglutide.

This study will compare the new medicine IcoSema, which is a combination of insulin icodec and semaglutide, taken once a week, to semaglutide taken once a week in people with type 2 diabetes.

The study will look at how well IcoSema controls blood sugar level in people with type 2 diabetes compared to semaglutide.

Participants will either get IcoSema or semaglutide.

It had two arms (groups): IcoSema (experimental) and Semaglutide (experimental).

The registry classes the interventions as drug.

Who Took Part

683 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Male or female and age above or equal to 18 years at the time of signing informed consent. Diagnosed with type 2 diabetes mellitus 180 days or more before screening. Insulin naïve. The following exceptions are permitted: short term insulin treatment for a maximum of 14 days before screening and/or prior insulin treatment for gestational diabetes. Body mass index (BMI) below or equal to 40.0 kg/m\^2.

The full record lists 6 inclusion and 8 exclusion criteria; among the exclusions: treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening; any episodes (as declared by the participant or in the medical records) of diabetic ketoacidosis within 90 days before screening; presence or history of pancreatitis (acute or chronic) within 180 days before screening.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

It started in 2022-04-11 with completion listed for 2023-12-13.

It ran at 193 sites in United States (76), Canada (24), China (12), Japan (11), France (10) and Greece (9).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change From Baseline in Glycosylated Haemoglobin (HbA1c) (time frame: Baseline (week 0), (week 52)).

It also tracked 5 secondary outcomes, for example Change From Baseline in Fasting Plasma Glucose (FPG), Change From Baseline in Body Weight and Number of Severe Hypoglycaemic Episodes (Level 3).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 683 people.

With 683 participants it is a large trial for this field.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Semaglutide compound page, all human trials.