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Data from a clinical trial has shown that oral semaglutide can be effective in reducing the risk of major cardiovascular events (MACE) in adult patients with type 2 diabetes.

The study labeled SOUL demonstrated that there was a 14% decrease in MACE in participants administered with Novo Nordisk’s brand of oral semaglutide (Rybelsus), showing superior efficacy compared to those who received a placebo.

Patients with poorly controlled type 2 diabetes use oral semaglutide as an adjunct to physical activity and diet to improve blood sugar control.

It is administered once daily and is approved for use in three doses: 3 mg, 7mg and 14 mg.

SOUL, a 2019-initiated phase III trial, recruited a total of 9650 participants who had a prior diagnosis of type 2 diabetes with established cardiovascular disease and/or chronic kidney disease.

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49% of patients received Rybelsus, while the rest received a placebo as an adjunct to standard care for the prevention of MACE defined as cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke.

"We are pleased to see that the results from SOUL demonstrate that oral semaglutide reduces the risk of cardiovascular events and that the benefits of oral semaglutide come on top of the standard of care," said Martin Holst Lange, Head of Development, Novo Nordisk.

Around the beginning of the year, Novo Nordisk plans to submit a label expansion application for Rybelsus® in the US and the European Union for regulatory approval.

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