Photograph used for representational purposes only
| Photo Credit: Getty Images
Diabetes management shouldn’t be focused narrowly on blood sugar levels, but must concurrently work at protecting cardiac and renal health too, states a recent study that found daily oral semaglutide (an anti-diabetic medication used for the treatment of type 2 diabetes and an anti-obesity medication used for long-term weight management) could cut the risk of heart attacks, strokes and cardiovascular death by 14%.
In a phase three trial of people with diabetes, the study, called SOUL, tested Rybelsus – Novo Nordisk’s diabetes drug administered in oral form – against a placebo, in trial participants already receiving standard medications.
The study of this oral form of GLP-1 Receptor Agonists (GLP-1RAs) was a multicentre, international, randomised, double-blind, parallel-group, placebo-controlled, phase three cardiovascular outcomes trial, with 9,650 people enrolled. In India, there were 32 centres and 788 people enrolled.
Semaglutide was initially approved in June 2021 for chronic weight management in those with obesity or overweight and at least one weight-related condition, including high blood pressure, type 2 diabetes, or high cholesterol, in addition to diet and increased exercise.
The SOUL trial was initiated in 2019. The key objective of SOUL was to demonstrate that oral semaglutide lowers the risk of major adverse cardiovascular events (a composite endpoint consisting of cardiovascular death, non-fatal myocardial infarction and non-fatal stroke) compared to placebo, both added to standard of care in patients with type 2 diabetes and established Cardiovascular Disease (CVD) and Chronic Kidney Disease (CKD).
A recent study from the Indian Council of Medical Research reveals that, in 2021, India had over 100 million people living with diabetes. The National Family Health Survey (2019-21) reported that nearly nearly 23% of women and 22.1% of men are overweight as per the BMI criterion. Additionally, in terms of abdominal obesity, 40% of women and 12% of men are abdominally obese in the country.
“The SOUL trial demonstrates statistically significant reductions in the primary composite endpoint of major adverse cardiovascular events (MACE), encompassing myocardial infarction, stroke, or cardiovascular death, in adults with type 2 diabetes mellitus (T2DM) and established CVD and/or CKD. This data reinforces oral semaglutide’s role as the first and only approved oral glucagon-like peptide-1 receptor agonist (GLP-1 RA) to achieve a significant reduction in cardiovascular risk within this high-risk population. This achievement enhances the existing standards of care for managing both T2DM and CVD, offering patients an innovative and effective therapeutic intervention. The observed impact of oral semaglutide on cardiovascular outcomes underscores its potential to address a critical unmet need in cardiometabolic disease management,” V. Mohan, chairman, Dr. Mohan’s Diabetes Specialities Centre, said.
A.G. Unnikrishnan, CEO and chief of Endocrinology at the Chellaram Diabetes Institute, Pune added that the SOUL trial on oral semaglutide has shown that it can reduce the risk of major cardiovascular events (MACE), regardless of whether participants were already using sodium-glucose cotransporter-2 inhibitor (SGLT2i). He said that the benefits were consistent for everyone – those on SGLT2i and those without – during the trial.
“What is even better is that combining these two treatments was a safe approach, opening the door to a more comprehensive, all-rounded approach to managing type 2 diabetes. This breakthrough not only transforms care for people living with type 2 diabetes but also sets a new standard for scientific innovation,” he said.
Published – April 05, 2025 05:07 pm IST