A Research Study to Compare Semaglutide to Insulin Aspart, When Taken Together With Metformin and Insulin Glargine, in People With Type 2 Diabetes

What Was Tested

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

This study will compare the effect of semaglutide once weekly to insulin aspart 3 times daily as add on to metformin and insulin glargine in people with type 2 diabetes.

Participants will either get insulin glargine and semaglutide or insulin glargine and insulin aspart - which treatment the participant get is decided by chance.

Insulin glargine is taken once a day and semaglutide once a week.

It had two arms (groups): Semaglutide (experimental) and Insulin aspart (active comparator).

The registry classes the interventions as drug.

Who Took Part

2274 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, age greater than or equal to 18 years at the time of signing informed consent. Diagnosed with type 2 diabetes greater than or equal to 180 days prior to the day of screening. Treated with basal insulin once daily or twice daily for greater than or equal to 90 days prior to the day of screening.

The full record lists 5 inclusion and 6 exclusion criteria; among the exclusions: history or presence of pancreatitis (acute or chronic); subjects presently classified as being in new york heart association class iv; planned coronary, carotid or peripheral artery revascularisation known on the day of screening.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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

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

Being open-label, the Semaglutide study did not mask who received what.

It started in 2018-10-01 with completion listed for 2021-02-22.

It ran at 210 sites in Germany (31), India (22), Poland (20), Greece (14), Turkey (Türkiye) (14) and Slovakia (11).

Its stated primary purpose is treatment.

What Was Measured

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

It also tracked 24 secondary outcomes, for example Number of Event Adjudication Committee-confirmed Severe Hypoglycaemic Episodes (ADA) From Randomization to Week 52, Change From Baseline to Week 52 in Body Weight (Kilogram (kg)), Change From Baseline to Week 52 in Fasting Plasma Glucose (FPG), Change From Baseline to Week 52 in 7-point Self-measured Plasma Glucose Profile (SMPG ): Mean 7-point Profile (7-PP), Change From Baseline to Week 52 in 7-point Self-measured Plasma Glucose Profile: Mean Post-prandial Increment (Over All Meals) and Change From Baseline to Week 52 in Body Mass Index (BMI).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide and Insulin Glargine in 2274 people.

With 2274 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 and the Insulin Glargine compound page, all human trials.