A Research Study to Compare Two Types of Insulin, a New Weekly Insulin, Insulin Icodec and an Available Daily Insulin, Insulin Glargine, Both in Combination With Mealtime Insulin, in People With Type 2 Diabetes Who Use Daily Insulin and Mealtime Insulin (ONWARDS 4)

What Was Tested

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

This study compares insulin icodec (a new insulin taken once a week) to insulin glargine (an insulin taken once daily which is already available on the market) in people with type 2 diabetes.

The study will look at how well insulin icodec taken weekly controls blood sugar compared to insulin glargine taken daily.

Participants will either get insulin icodec that participants will have to inject once a week on the same day of the week or insulin glargine that participants will have to inject once a day at the same time every day.

It had two arms (groups): insulin icodec + insulin aspart (experimental) and Insulin glargine + insulin aspart (active comparator).

Participants will get once weekly injections in combination with 2-4 times daily injections of insulin aspart.

Participants will get once daily injections in combination with 2-4 times daily injections of insulin aspart.

The registry classes the interventions as drug.

Who Took Part

582 actual participants took part.

It was open to people of any sex.

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

Examples of who could join: Male or female aged above or equal to 18 years at the time of signing informed consent. Diagnosed with type 2 diabetes mellitus (T2D) greater than or equal to 180 days prior to the day of screening. Body mass index (BMI) below or equal to 40.0 kg/m\^2.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: any episodes (as declared by the subject or in the medical records.) of diabetic ketoacidosis within 90 days prior to the day of screening; myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening; chronic heart failure classified as being in new york heart association class iv at screening.

How the Study Was Run

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

The participants were allocated by chance, so the Insulin Glargine group and the comparison group should start out alike.

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 2021-05-14 with completion listed for 2022-06-16.

It ran at 116 sites in United States (52), India (17), Russia (11), Japan (9), Netherlands (7) and Italy (6).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in Glycated Haemoglobin (HbA1c) (time frame: Baseline (week 0), Week 26).

It also tracked 9 secondary outcomes, for example Change in Fasting Plasma Glucose (FPG), Number of Severe Hypoglycaemic Episodes (Level 3) and Change in Body Weight.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine and Insulin Aspart in 582 people.

With 582 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 Insulin Glargine compound page and the Insulin Aspart compound page, all human trials.