A Research Study to Compare a New Weekly Insulin, Insulin Icodec, and an Available Daily Insulin, Insulin Degludec, Both in Combination With Mealtime Insulin in People With Type 1 Diabetes (ONWARDS 6)

What Was Tested

In this phase 3 trial, researchers set out to test Insulin Aspart.

This study compares insulin icodec (a new insulin) to insulin degludec (an insulin already available on the market) in people with type 1 diabetes.

The study will look at how well insulin icodec taken weekly controls blood sugar compared to insulin degludec 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 degludec 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 degludec + insulin aspart (active comparator).

Insulin icodec once a week in combination with 2-4 times daily injections of insulin aspart at meal times.

Insulin degludec once a day in combination with 2-4 times daily injections of insulin aspart at meal times.

The registry classes the interventions as drug.

Who Took Part

582 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 aged greater than or equal to 18 years at the time of signing informed consent. Diagnosed with type 1 diabetes mellitus greater than or equal to 1 year prior to the day of screening. Treated with multiple daily insulin injections (basal and bolus insulin analogue regimes) greater than or equal to 1 year prior to the day of screening.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening; chronic heart failure classified as new york heart association (nyha) class iv at 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 Insulin Aspart and who got the comparison, which limits bias.

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

Everyone knew when Insulin Aspart was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2021-04-30 with completion listed for 2022-04-28.

It ran at 130 sites in United States (42), Russia (14), Canada (10), Germany (10), India (8) and United Kingdom (8).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in Glycosylated Haemoglobin (HbA1c) at Week 26 (time frame: Baseline (week 0), week 26).

It also tracked 17 secondary outcomes, for example Change in Glycosylated Haemoglobin (HbA1c) at Week 52, Change in Fasting Plasma Glucose (FPG), Change in Diabetes Treatment Satisfaction Questionnaire (DTSQs) in Total Treatment Satisfaction, Number of Severe Hypoglycaemic Episodes (Level 3): From Baseline (Week 0) to Week 26, Number of Severe Hypoglycaemic Episodes (Level 3): From Baseline (Week 0) to Week 57 and Change in Body Weight.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of 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 Aspart compound page, all human trials.