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 Insulin Glargine Taken Daily With Insulin Aspart (COMBINE 3)

What Was Tested

The trial (phase 3) is built around Insulin Glargine and Insulin Aspart.

This study will compare the new medicine IcoSema, which is a combination of insulin icodec and semaglutide, taken once a week, to insulin glargine taken daily with insulin aspart 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 insulin glargine taken with insulin aspart.

Participants will either get IcoSema or insulin glargine taken with insulin aspart.

Which treatment participants get is decided by chance.

It had two arms (groups): IcoSema (experimental) and Insuling glargine/insulin aspart (active comparator).

Participants will receive once weekly subcutaneous (s.c) injections of IcoSema during the 52-week treatment period.

Participants will receive subcutaneous (s.c) injections of insulin glargine once daily combined with 2-4 times daily injections of insulin aspart.

The registry classes the interventions as drug.

Who Took Part

679 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. Sodium-glucose co-transporter 2 inhibitors. Marketed oral combination products only including the products listed above. Body mass index (BMI) less than or equal to 40.0 kg/m\^2.

The full record lists 14 inclusion and 9 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 of diabetic ketoacidosis within 90 days before screening. as declared by the participant or in the medical records; presence or history of pancreatitis (acute or chronic) within 180 days before screening.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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.

The Insulin Glargine group and the comparison group ran side by side rather than switching.

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

It started in 2021-11-30 with completion listed for 2023-11-14.

It ran at 182 sites in United States (66), India (19), Czechia (14), Japan (13), Malaysia (11) and Poland (9).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in HbA1c (time frame: From baseline week 0 (V2) to week 52 (V54)).

It also tracked 10 secondary outcomes, for example Change in body weight, Change in fasting plasma glucose (FPG), Change in Diabetes Treatment Satisfaction Questionnaire (DTSQs) in total treatment satisfaction and Number of severe hypoglycaemic episodes (level 3).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine and Insulin Aspart in 679 people.

With 679 participants it is a large trial for this field.

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 and the Insulin Aspart compound page, all human trials.