Dundee, Scotland, Oct. 25, 2023 — Researchers at the University of Dundee have received a grant from JDRF, the leading global type 1 diabetes (T1D) research and advocacy organization to support a UK-wide clinical trial that could potentially advance a new life-saving treatment for people with T1D and heart failure.
The £1.5 million SOPHIST trial will be led by the University’s Dr Ify Mordi, a Senior Lecturer in Cardiology. Dr. Mordi and his colleagues from Dundee’s School of Medicine will study the effect of a drug called sotagliflozin on quality of life in approximately 300 people across the UK. Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), developer of sotagliflozin, will provide the study medication for the trial.
More than 400,000 people in the UK live with T1D, while almost 1 million people have a diagnosis of heart failure. The two conditions are closely linked, and recent research has shown that people with T1D who develop heart failure are more likely to be admitted to hospital or die at an earlier age than patients with type 2 diabetes or those without diabetes who develop heart failure.
Sotagliflozin belongs to a class of prescription medicines called SGLT inhibitors that are used with diet and exercise to lower blood sugar and improve heart and kidney health in adults with type 2 diabetes. SGLT inhibitors have been tested for glucose control in people with T1D, but not for heart and kidney health.
As the first large trial anywhere in the world studying an SGLT inhibitor in people with type 1 diabetes and heart failure, SOPHIST will seek to address this knowledge gap.
Dr Mordi said, “SGLT inhibitors have been adopted as a key life-saving treatment in heart failure patients with type 2 diabetes or without diabetes over the past five years, improving patients’ quality of life and preventing hospital admissions.
“Unfortunately, because of initial concerns about diabetic ketoacidosis, patients with type 1 diabetes and heart failure were not included in the trials that confirmed the benefits of SGLT inhibitors in heart failure.
“Recent studies have shown that with appropriate strategies and education, SGLT inhibitors can be used safely in people with type 1 diabetes. Heart failure in people with type 1 diabetes is similar to heart failure in other patient groups, so we would hope that SGLT inhibitors would have similar benefits, but we need evidence to confirm our hypothesis.
“This trial is much needed, and if we do find that sotagliflozin improves quality of life compared to placebo in people with type 1 diabetes and heart failure, then this could have a significant impact on clinical practice worldwide, potentially changing treatment guidelines. We are extremely grateful to Breakthrough T1D and Lexicon for supporting this vital study that could improve the lives of thousands of patients.
“Heart failure is a devastating complication of type 1 diabetes that has not been adequately studied or addressed. Sotagliflozin was recently approved by the FDA for heart failure, and this trial will evaluate its efficacy and safety specifically in people with heart failure who have T1D,” said Jonathan Rosen, PhD, Breakthrough T1D director of research. “Breakthrough T1D is committed to developing life-changing therapies for people with T1D who have not been able to benefit from recent therapeutic advances in heart and kidney disease.”
The trial is being supported by the Tayside Clinical Trials Unit and includes cardiologists and diabetes specialists from across the UK and will begin recruitment in early 2024.
About Breakthrough T1D
JDRF’s mission is to accelerate life-changing breakthroughs to cure, prevent and treat T1D and its complications. To accomplish this, Breakthrough T1D has invested more than $2.5 billion in research funding since our inception. We are an organization built on a grassroots model of people connecting in their local communities, collaborating regionally and globally for efficiency and broader fundraising impact, and uniting on a global stage to pool resources, passion, and energy. We collaborate with academic institutions, policymakers, and corporate and industry partners to develop and deliver a pipeline of innovative therapies to people living with T1D. Our staff and volunteers throughout the United States and our five international affiliates are dedicated to advocacy, community engagement, and our vision of a world without T1D. For more information, please visit jdrf.org or follow us on Twitter (@JDRF), Facebook (@myjdrf), and Instagram (@jdrfhq).
About Type 1 Diabetes (T1D)
T1D is an autoimmune condition that causes the pancreas to make very little insulin or none at all. This leads to dependence on insulin therapy and the risk of short or long-term complications, which can include highs and lows in blood sugar; damage to the kidneys, eyes, nerves, and heart; and even death if left untreated. Globally, it impacts nearly 9 million people. Many believe T1D is only diagnosed in childhood and adolescence, but diagnosis in adulthood is common and accounts for nearly 50% of all T1D diagnoses. The onset of T1D has nothing to do with diet or lifestyle. While its causes are not yet entirely understood, scientists believe that both genetic factors and environmental triggers are involved. There is currently no cure for T1D.
