Major international clinical trial finds ‘significant’ impact of semaglutide on people with type 2 diabetes

An international clinical trial, led in the UK by Swansea’s Joint Clinical Research Facility (JCRF), has found that semaglutide tablets – best known as the active ingredient in some weight-loss treatments – can ‘significantly’ help reduce the risk of heart attacks in adults who have type 2 diabetes and cardiovascular and/or chronic kidney disease.

The SOUL trial, sponsored by Novo Nordisk, was a multicentre, international, randomised, double-blind, parallel-group, placebo-controlled, phase 3 cardiovascular outcomes trial with 9,650 people enrolled.  The trial found a 14% reduction in risk of major adverse cardiovascular events (MACE) in adults with type 2 diabetes and CVD and/or CKD when treated with Rybelsus® semaglutide tablets at 14mg, compared to a placebo.

Having type 2 diabetes directly increases the risk of developing associated cardiometabolic diseases, while also contributing to the progression of other cardiovascular risk factors. Nearly one in three adults living with type 2 diabetes also live with cardiovascular disease.

Professor Steve Bain, Health and Care Research Wales Specialty Lead for Diabetes, who was co-chair of the global panel of investigators on the trial, welcomed the full results which were presented recently at the American College of Cardiology's (ACC) Annual Scientific Session.

Professor Bain, who is Assistant Medical Director for Research & Development at Swansea Bay University Health Board, and Clinical Director of the Diabetes Research Unit in Swansea University, added: “These findings give new insights into how well semaglutide tablets work and provides more information about the safety profile for people with type 2 diabetes who also have heart or kidney problems.

“Cardiovascular disease is a significant health challenge for many people living with type 2 diabetes, and these data provide meaningful scientific insights in this area of unmet need.”

Semaglutide tablets, which are licensed in the UK, demonstrated this risk reduction in patients who were already receiving treatment with established standards of cardiovascular and diabetes care.

Based on the SOUL findings, Novo Nordisk has submitted a label extension application for Rybelsus® (semaglutide tablets) for cardiovascular event risk reduction in adults living with type 2 diabetes to the UK Medicines and Healthcare products Regulatory Agency (MHRA), US Food and Drug Administration (FDA) and European Medicines Agency (EMA).