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Home > About Breakthrough T1D UK & our impact > Our research > Research projects > The SOPHIST Trial: sotagliflozin for people with type 1 and heart failure
People with type 1 are at higher risk of heart diseases such as heart attacks and heart failure. Up to 5% of people with type 1 diabetes have heart failure. In people with heart failure, their heart can’t pump blood around the body effectively, which causes breathlessness, tiredness and ankle swelling. Find out more about heart problems as a complication of diabetes.
Sotagliflozin is an SGLT2 inhibitor, like dapagliflozin, which used to be licensed in the UK for type 1. It is a drug used to treat heart failure and it also helps to lower blood sugar levels by reducing how much glucose is reabsorbed back into the bloodstream by the kidneys.
In the UK, sotagliflozin is licensed for people who have heart failure with type 2 diabetes and without diabetes. It is also licensed for people with type 1 in mainland Europe to help manage blood glucose levels. Ify’s project is to generate evidence which will allow us to extend the use of this life-saving medication to people with type 1 diabetes and heart failure in the UK.
Sotagliflozin improves quality of life and reduces hospital admissions and deaths in people with heart failure by roughly a third. But it carries an increased risk of diabetic ketoacidosis (DKA), so people with type 1 weren’t included in previous clinical trials due to safety concerns. We now know more about reducing the risk of DKA, so people with type 1 can now take part in clinical trials of sotagliflozin. The causes of heart failure are similar in people with both type 1 and 2 diabetes and those without diabetes, so sotagliflozin is likely to be safe and effective in patients with type 1 diabetes too.
Ify’s Breakthrough T1D UK-funded clinical trial is known as SOPHIST (Sotagliflozin in Patients with Heart Failure Symptoms and Type 1 Diabetes). SOPHIST will take place at seven hospitals across Scotland in 296 adults with type 1 diabetes and heart failure.
His research team will randomly split the participants into two groups. One group will take sotagliflozin for 12 weeks and the other will take a placebo (a non-active pill) for 12 weeks.
Neither the research team nor the participants will know which pill they are taking until the clinical trial has finished. Ify’s team will be in regular contact with the people taking part and will teach them how to reduce their risk of complications such as DKA.
Ify will use the Kansas City Cardiomyopathy Questionnaire (KCCQ) score, which is a questionnaire where patients report their heart failure symptoms and how they affect their physical and mental health. Improvements in the KCCQ score from the start to the end of the study will show the potential benefit of sotagliflozin.
As well as the KCCQ questionnaire, Ify will give his participants a blood test to look for heart muscle strain and HbA1c. He will also collect continuous glucose sensor data, ketone levels and will measure how far patients can walk over 6 minutes.
If the SOPHIST trial shows that sotagliflozin improves quality of life of people with type 1 and heart failure, without any safety issues, it would provide evidence for the drug to be given to this group of people. This could lead to changes in current treatment guidance to allow people living with heart failure and type 1 to take sotagliflozin.
The evidence from this study would also help support a wider campaign for people with type 1 who don’t have heart failure to access sotaglifolzin to help manage their blood glucose levels – like they can in Europe. Therefore, this clinical trial has the potential to improve the lives of many people with type 1 in the UK.
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