RESEARCHERS at the University of Dundee have received a grant from JDRF to to support a UK-wide diabetes clinical trial.
The trial could potentially advance a new life-saving treatment for people with type 1 diabetes (T1D) and heart failure.
The £1.5m 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.
More than 400,000 people in the UK live with T1D, while almost 1 million people have a diagnosis of heart failure.
Sotagliflozin belongs to a class of prescription medicines called SGLT inhibitors. 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 researching 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, patients with type 1 diabetes and heart failure were not included in the trials that confirmed the benefits of SGLT inhibitors in heart failure.
“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.
“This trial is much needed, and this could have a significant impact on clinical practice worldwide, potentially changing treatment guidelines.
We are extremely grateful to JDRF and Lexicon for supporting this vital study that could improve the lives of thousands of patients.”
Jonathan Rosen, PhD, JDRF Director of Research, said, “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.
“JDRF 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.