RecruitingPhase IIInterventional

Sotagliflozin in patients with heart failure symptoms and type 1 diabetes

Heart failure can cause tiredness, breathlessness, and swollen ankles, making day-to-day life difficult. While new treatments help people with type 2 diabetes manage heart failure, doctors do not yet know if these benefits apply to type 1 diabetes. This trial investigates a tablet called sotagliflozin in adults with both type 1 diabetes and heart failure symptoms. Participants will take either sotagliflozin or a dummy tablet (placebo) once daily for 4 months, alongside their usual insulin. Researchers will measure whether the tablet improves daily wellbeing and heart symptoms. Safety is a top priority. Because these medications can alter blood sugar and ketone levels, the study team provides close monitoring, continuous glucose sensors, and detailed guidance. The whole study lasts around 6 months, and many check-ups can happen over the phone or by video call.

At a glance

Status

Recruiting

Phase

Phase II

Sponsor

University of Dundee

Enrolment target

320

Start

28 Jan 2025

Estimated completion

30 Apr 2027

Type 1 Diabetes, Heart Failure

What is this study about?

Living with type 1 diabetes means carefully balancing insulin and blood sugar every single day. Over time, some people also develop heart failure. This does not mean the heart has stopped working, but rather that it is not pumping blood as efficiently as it should. It often causes persistent tiredness, shortness of breath during daily activities, and swollen ankles, which can make everyday life exhausting and lead to hospital stays.

In recent years, a group of medicines called SGLT inhibitors has transformed heart failure care for people with type 2 diabetes. These drugs help the body remove extra fluid and sugar through urine, taking strain off the heart. However, people with type 1 diabetes were not included in those earlier studies. Doctors now want to find out if a tablet called sotagliflozin can provide the same relief to those living with type 1 diabetes.

This study matters because there are currently limited heart failure treatments tailored to the specific needs of people with type 1 diabetes. By testing whether sotagliflozin eases symptoms and improves everyday energy and quality of life, researchers hope to provide evidence for a helpful new treatment option.

Key takeaways

Tests whether the tablet sotagliflozin improves daily life for adults with type 1 diabetes and heart failure.
Participants take either the real tablet or a dummy pill once daily for 4 months.
Total involvement lasts about 6 months, with some visits possible via video or phone.
The study provides close monitoring, CGM support, and ketone testing kits to keep you safe.
Taking part is entirely voluntary and will not harm your relationship with your regular healthcare team.

Who may be eligible?

This study is open to adults aged between 18 and 84 who have type 1 diabetes and experience heart failure symptoms. To qualify, you should already be using a continuous glucose monitor (CGM) or be happy to wear one during the study. You will also need to be taking a certain amount of daily insulin or have a body mass index (BMI) of 25 or above.

Your heart failure must be confirmed by medical tests or previous hospital records. This can include signs of strain on heart scans, a previous hospital stay for fluid build-up, or specific blood test results that show your heart is working under stress.

You cannot take part if you do not have type 1 diabetes, if you are outside the age range, or if your heart failure symptoms do not currently affect your day-to-day life. The study doctors will review your full medical history to make sure taking part is completely safe for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am aged between 18 and 84 years old.
I have been diagnosed with type 1 diabetes.
I have been diagnosed with heart failure, or have had hospital care for heart strain.
I experience heart symptoms like breathlessness, tiredness, or swollen ankles.
I currently use a continuous glucose monitor (CGM) or am willing to wear one.
I am willing to check my blood ketone levels at home when advised.

Answer every question to see your result.

What does participation involve?

If you decide to join, you will be part of the study for around 6 months in total. You will be placed into one of two groups by chance (like flipping a coin). One group will take a daily sotagliflozin tablet for 4 months, while the other group will take an identical-looking dummy tablet (placebo). Neither you nor the study doctors will know which tablet you are taking until the study ends.

You will continue your usual insulin, and the team will help adjust your doses to keep your blood sugar steady. You will use a continuous glucose monitor and test your blood ketone levels at specific key times, such as before and after starting the medication. You will also complete questionnaires about your quality of life and have simple blood tests to check your kidney function. To make taking part as easy as possible, several check-ups can be done from home via telephone or video call.

Potential risks and benefits

Taking part may help improve your heart failure symptoms, such as breathlessness, and could help your blood sugar control, though this cannot be guaranteed. You will also receive extra specialist reviews of your diabetes care. However, medications like sotagliflozin carry potential risks for people with type 1 diabetes. These include a small risk of diabetic ketoacidosis (DKA), hypos (low blood sugar), thrush or urinary tract infections, and dehydration. The research team will give you clear safety plans, ketone meters, and close monitoring to keep you safe. Joining is completely voluntary, and you are free to withdraw at any time without your regular NHS care being affected.

Locations (17)

Ninewells Hospital
Approximate
Dundee, Scotland
Leicester General Hospital
Approximate
Leicester, England
Moorgreen Hospital
City only
Southampton, England
Addenbrookes
Approximate
Cambridge, England
Wythenshawe Hospital
Approximate
Manchester, England
St George's Healthcare Nhst
Unverified
London, England
Royal Infirmary of Edinburgh
Unverified
Lothian, Scotland
Prince Philip Hospital
Unverified
Llanelli, Wales
Glasgow Royal Infirmary
Unverified
Glasgow, Scotland
Manchester Royal Royal Infirmary
Unverified
Manchester, England
North Manchester Healthcare NHS Trust
Unverified
Manchester, England
Aberdeen Royal Infirmary
Unverified
Aberdeen, Scotland

Common questions

What is a placebo?

A placebo is a dummy tablet that looks identical to the real medication but contains no active medicine. Comparing results against a placebo helps researchers prove whether the real drug actually works.

Do I have to stop taking my regular insulin?

No. You will continue taking your insulin as prescribed, though your study doctor may slightly reduce your dose at the start to prevent low blood sugar.

How often will I need to visit the hospital?

The team aims to keep hospital trips low. While you will need in-person visits for initial tests and blood checks, many follow-ups can take place by phone or video.

What extra testing will I need to do at home?

You will wear a continuous glucose monitor (CGM) and will be asked to check your blood ketone levels using a finger-prick meter at specific times, especially when starting the tablets.

Will taking part affect my usual NHS treatment?

No. The trial team works alongside your usual care. If they spot any health concerns during tests, they will discuss them with you and your GP.

How to find out more

Susan Long

sophist-trial@dundee.ac.uk +44 (0)1382 388596 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.