A Research Study to Compare Two Types of Insulin, a New Insulin, Insulin Icodec and an Available Insulin, Insulin Glargine, in People With Type 2 Diabetes Who Have Not Used Insulin Before

What Was Tested

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

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 (experimental) and Insulin glargine (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 984 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 above or equal to 18 years at the time of signing informed consent. Diagnosed with type 2 diabetes mellitus (T2D) 180 days or more prior to the day of screening. Insulin naïve. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes. Body mass index (BMI) equal to or below 40.0 kg/m\^2.

The full record lists 6 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.

Random assignment meant chance, not the researchers, decided who got Insulin Glargine 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 Insulin Glargine study: the participants and staff both knew the treatment.

It started in 2020-11-25 with completion listed for 2022-05-29.

It ran at 198 sites in United States (97), United Kingdom (16), Japan (15), Russia (14), India (12) and Poland (8).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in Glycated Haemoglobin (HbA1c) (time frame: Baseline (week 0), Week 52).

It also tracked 12 secondary outcomes, for example Change in Fasting Plasma Glucose (FPG), Number of Severe Hypoglycaemic Episodes (Level 3) Until Week 52, Number of Severe Hypoglycaemic Episodes (Level 3) Until Week 83 and Change in Body Weight.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine in 984 people.

With 984 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, all human trials.