Sotagliflozin in Patients With Heart Failure Symptoms and Type 1 Diabetes
This study is investigating if a new tablet, sotagliflozin, can help people who have both type 1 diabetes and heart failure. Heart failure can cause symptoms like breathlessness and tiredness, which affect daily life. Previous studies showed sotagliflozin helped people with type 2 diabetes and heart failure, but we don't know if it will help people with type 1 diabetes too. We're looking to see if this tablet improves quality of life and is safe for this group. Participants will take either the study drug or a dummy pill for four months, and neither they nor the doctors will know who is getting what until the study ends. The total study will last about 26 months.
نظرة سريعة
ما هو موضوع هذه الدراسة؟
Heart failure can be a difficult condition for anyone, but it can also affect people living with type 1 diabetes. It can make everyday activities challenging due to symptoms like feeling short of breath, very tired, or having swollen ankles. These symptoms can affect your quality of life and sometimes lead to hospital stays. This study aims to find out if a new tablet called sotagliflozin could help improve these symptoms and overall quality of life for people with type 1 diabetes and heart failure.
Sotagliflozin has previously been shown to help people with type 2 diabetes and heart failure by improving their symptoms and reducing their chances of being admitted to hospital. However, we don't know if these same benefits apply to people with type 1 diabetes, as they weren't included in those earlier studies. This current study will help us understand if sotagliflozin is also effective and safe for people with type 1 diabetes who have heart failure.
To do this, we are looking for about 320 people with type 1 diabetes and heart failure symptoms across the UK to take part. Participants will be split into two groups by chance: one group will receive sotagliflozin, and the other will receive a 'placebo', which is a dummy tablet that looks exactly like the real one but contains no active medicine. This allows us to fairly compare the effects of the treatment. Neither you nor your doctor will know which tablet you are taking until the study is over. We hope this research will provide important answers to help improve care for people with type 1 diabetes and heart failure.
النقاط الرئيسية
- This study investigates a new tablet, sotagliflozin, for people with type 1 diabetes and heart failure.
- It aims to improve quality of life and heart failure symptoms.
- سيأخذ المشاركون إما الدواء التجريبي أو حبة وهمية.
- The study lasts about six months, with four months of daily tablet taking.
- Participation involves regular check-ups and using a continuous glucose monitor.
- It could offer closer medical monitoring and a potential new treatment.
من قد يكون مؤهلاً؟
This study is looking for adults aged between 18 and 84 years old who have type 1 diabetes. You would also need to have been diagnosed with heart failure, or be at high risk of developing it. This means your doctor might have found certain signs like specific levels in a blood test, or changes in your heart seen on scans.
To be considered, you also need to be using a continuous glucose monitor (CGM) or be willing to use one during the study. Additionally, your heart failure symptoms should be of a certain level, generally meaning they might affect your daily activities to some extent, but are not so severe that you need constant hospital care.
There are some reasons why you might not be able to join. For example, if you've recently had heart surgery, a heart attack, or had a special heart device fitted within the last month. Also, if you have very severe heart failure that requires mechanical support, you wouldn't be able to take part. The study team will review all your medical information to confirm if you are a good fit.
هل يمكن أن تناسبك هذه الدراسة؟
أجب عن هذه الأسئلة السريعة لترى ما إذا كنت مؤهلاً. هذا دليل فقط - الفريق البحثي هو الذي يتخذ القرار النهائي.
- Are you between 18 and 84 years old?
- Do you have type 1 diabetes?
- Have you been diagnosed with heart failure, or are you at high risk for it?
- Are your heart failure symptoms affecting your daily life?
- Are you using (or willing to use) a continuous glucose monitor?
ماذا يتضمن المشاركة؟
If you decide to take part, you would be involved in the study for a total of around six months. For four of those months, you would take one tablet each day, which would either be sotagliflozin or a dummy pill (placebo). You won't know which one you're taking, and neither will your medical team, until the study concludes. During this time, you'll have regular hospital visits to check your health, symptoms, and how you're feeling. You'll also be asked to use a continuous glucose monitor (CGM) throughout the study to track your blood sugar levels. There will be various assessments during these visits, including blood tests and possibly heart checks, to see how the treatment is affecting you. Your progress will be carefully monitored to evaluate both the benefits and any potential side effects.
المخاطر والفوائد المحتملة
المواقع (17)
- مستشفى أبردين الملكيالرمز البريدي المؤكدأبردين، المملكة المتحدة· التوظيف
- Addenbrookes Hospitalالرمز البريدي المؤكدكامبريدج، المملكة المتحدة· التوظيف
- مستشفى ناينويلزالرمز البريدي المؤكددندي، المملكة المتحدة· التوظيف
- Royal Infirmary of Edinburghالرمز البريدي المؤكدإدنبرة، المملكة المتحدة· التوظيف
- Glasgow Royal Infirmary, Glasgow Clinical Research Facilityالرمز البريدي المؤكدغلاسكو، المملكة المتحدة· التوظيف
- Leicester General Hospitalالرمز البريدي المؤكدليستر، المملكة المتحدة· التوظيف
- Aintree University Hospitalالرمز البريدي المؤكدليفربول، المملكة المتحدة· التوظيف
- Prince Philip Hospitalالرمز البريدي المؤكدLlanelli, United Kingdom· التوظيف
- مستشفى جايالرمز البريدي المؤكدلندن، المملكة المتحدة· التوظيف
- St George's University Hospitals NHS Foundation Trustالرمز البريدي المؤكدلندن، المملكة المتحدة· التوظيف
- Manchester Royal Infirmary Hospitalالرمز البريدي المؤكدمانشستر، المملكة المتحدة· التوظيف
- North Manchester General Hospitalالرمز البريدي المؤكدمانشستر، المملكة المتحدة· التوظيف
أسئلة شائعة
What is sotagliflozin?
Sotagliflozin is a tablet specifically being tested to see if it can help people with type 1 diabetes and heart failure symptoms.
ما هو الدواء الوهمي؟
A placebo is a 'dummy' tablet that looks identical to the active drug but contains no medicine. It helps us compare the real effects of the treatment.
كم من الوقت سأكون في الدراسة؟
You'll be actively taking part in the study for about six months, including four months of taking the daily tablet.
هل سأعرف إذا كنت أحصل على الدواء الفعال أم الدواء الوهمي؟
No, neither you nor your doctor will know whether you are taking sotagliflozin or the placebo until the study is finished. This is called 'blinded' participation.
What will happen if I decide to stop participating?
You are free to leave the study at any time, for any reason, without it affecting the medical care you normally receive.
كيفية معرفة المزيد
Ify Mordi, MBChB, MD
تحدث دائمًا إلى طبيبك العام أو الأخصائي قبل اتخاذ قرار بالمشاركة في دراسة.
هل أنت مهتم بالمشاركة؟
نقاش
مناقشة المجتمع
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