Effects of oral semaglutide on cardiovascular outcomes in individuals with type 2 diabetes and established atherosclerotic cardiovascular disease and/or chronic kidney disease: Design and baseline characteristics of SOUL, a randomized trial

What Was Tested

Researchers studied Semaglutide in the context of atherosclerosis, cardiovascular disease & high blood pressure in this clinical study publication.

To describe the design of the SOUL trial (Semaglutide cardiOvascular oUtcomes triaL) and the baseline clinical data of its participants.

Who Took Part

By PubMed's age tags, the people studied were older adults, men only.

How the Study Was Run

In design terms this was a randomized, double-blind, placebo-controlled and parallel-group study.

Random assignment meant chance, not the researchers, decided who got Semaglutide and who got the comparison, which limits bias.

Neither the participants nor the staff measuring them knew who was on Semaglutide, so expectations could not easily colour the readings.

The comparison arm used a placebo, so changes seen with Semaglutide could be set against what happens without it.

The Semaglutide group and the comparison group ran side by side rather than switching.

In SOUL, the effects of oral semaglutide, the first oral glucagon-like peptide-1 receptor agonist, on the risk of cardiovascular (CV) events in individuals with type 2 diabetes and established atherosclerotic CV disease (ASCVD) and/or chronic kidney disease (CKD) will be assessed.

This event-driven trial will continue until 1225 first adjudication-confirmed MACEs have occurred.

What Was Measured

PubMed files the paper under topics including Diabetes Mellitus, Type 2, Cardiovascular Diseases, Sodium-Glucose Transporter 2 Inhibitors, Hypoglycemic Agents, Glucagon-Like Peptides, Renal Insufficiency, Chronic and Atherosclerosis.

The authors tagged it with the keywords GLP-1, randomized trial, semaglutide and type 2 diabetes.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Semaglutide in people with atherosclerosis, cardiovascular disease & high blood pressure.

Its findings take up roughly 5 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.

The publication is from 2023 (Diabetes, obesity & metabolism), a journal based in England.

More context: the Semaglutide compound page, Atherosclerosis, cardiovascular disease & high blood pressure research.