A Heart Disease Study of Semaglutide in Patients With Type 2 Diabetes

What Was Tested

The trial (phase 3) is built around Semaglutide.

The researchers are doing this study to look whether the type 2 diabetes medicine, semaglutide, has a positive effect on heart disease.

Participants will either get semaglutide tablets or placebo tablets ("dummy" medicine) - which treatment is decided by chance.

Participants must take one tablet with water every morning on an empty stomach and not eat or drink anything for at least 30 minutes.

It had two arms (groups): Oral semaglutide (experimental) and Placebo (placebo comparator).

One tablet daily for 3.5 to 5 years.

One tablet daily for 3.5 to 5 years.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 9651 actual participants took part.

It was open to people of any sex aged from 50 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 equal to or above 50 years at the time of signing informed consent. Diagnosed with type 2 diabetes mellitus. At least one of the below conditions (a-d):.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: planned coronary, carotid or peripheral artery revascularisation known on the day of screening; heart failure presently classified as being in new york heart association class iv; treatment with any glucagon-like peptide-1 receptor agonist within 30 days before screening.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Because people in this Semaglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

As a double-blind Semaglutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2019-06-17 with completion listed for 2024-08-23.

It ran at 492 sites in United States (91), India (41), Japan (34), Russia (21), United Kingdom (21) and Canada (18).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 24 secondary outcomes, for example Number of Participants From Randomisation to First Occurrence of Non-fatal Myocardial Infarction (MI), Number of Participants From Randomisation to First Occurrence of Non-fatal Stroke, Number of Participants From Randomisation to First Occurrence of Heart Failure Requiring Hospitalisation or Urgent Heart Failure Visit, Number of Participants From Randomisation to First Occurrence of Coronary Revascularisation, Number of Participants From Randomisation to First Occurrence of Unstable Angina Requiring Hospitalisation and Number of Participants From Randomisation to First Occurrence of Acute Limb Ischemia.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 9651 people.

With 9651 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, all human trials.