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.
Em resumo
Sobre o que é este estudo?
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.
Pontos principais
- 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.
Quem pode ser elegível?
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.
Este estudo pode ser adequado para você?
Responda a estas perguntas rápidas para ver se você pode ser elegível. Este é apenas um guia — a decisão final é da equipe de pesquisa.
- 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.
O que envolve a participação?
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.
Riscos e benefícios potenciais
Localizações (17)
- Ninewells HospitalAproximadoDundee, Scotland
- Hospital Geral de LeicesterAproximadoLeicester, Inglaterra
- Moorgreen HospitalApenas cidadeSouthampton, England
- AddenbrookesAproximadoCambridge, Inglaterra
- Hospital WythenshaweAproximadoManchester, England
- St George's Healthcare NhstNão verificadoLondon, England
- Hospital Real de EdimburgoNão verificadoLothian, Scotland
- Prince Philip HospitalNão verificadoLlanelli, Wales
- Glasgow Royal InfirmaryNão verificadoGlasgow, Scotland
- Manchester Royal Royal InfirmaryNão verificadoManchester, England
- North Manchester Healthcare NHS TrustNão verificadoManchester, England
- Aberdeen Royal InfirmaryNão verificadoAberdeen, Scotland
Perguntas frequentes
O que é um 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.
Como saber mais
Susan Long
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