ASPIRE-1; Individual and combined endothelin receptor and SGLT2 antagonism in adults with type 1 diabetes mellitus and chronic kidney disease: a Phase 2, multicenter, open-label randomized cross-over trial
Living with type 1 diabetes can sometimes cause strain on the kidneys over time, leading to chronic kidney disease. This study is testing two medicines: an established kidney tablet called dapagliflozin (Forxiga) and a study medicine named SC0062. Researchers want to find out whether taking both medicines together reduces protein in the urine—a key sign of kidney stress—better than taking SC0062 alone. Because this is a 'cross-over' study, participants will try different treatment combinations during the trial, with breaks in between. Doctors will also closely monitor safety, blood pressure, and markers of fluid build-up in the body. If you are 18 or older, have type 1 diabetes, and have signs of kidney disease, this research study may be relevant to you. Taking part is completely voluntary and will not affect your standard NHS diabetes care.
At a glance
What is this study about?
Type 1 diabetes is a lifelong condition where the body cannot produce its own insulin. Over many years, high blood sugar levels and high blood pressure can damage the tiny filters inside the kidneys. When these filters are damaged, protein starts leaking into the urine, which is an early sign of chronic kidney disease (CKD). Finding treatments that protect these delicate filters is essential to help people keep their kidneys healthy for as long as possible.
The ASPIRE-1 study focuses on two types of medicines designed to ease stress on the kidneys. One is dapagliflozin (also known by the brand name Forxiga), a tablet commonly used to protect the kidneys and heart. The other is a study medicine called SC0062, which works on different pathways in the blood vessels around the kidneys. Researchers want to know whether using both tablets together offers greater kidney protection than taking just one.
To find out, doctors measure something called the urine albumin-to-creatinine ratio (UACR). A lower UACR score means less protein is escaping into the urine, showing that the kidneys are under less strain. The study also tracks kidney function (eGFR), blood pressure, and markers of fluid retention to make sure the combination is both gentle on the body and safe to use.
This trial is important because people with type 1 diabetes currently have fewer specialised kidney-protecting treatment options compared to those with type 2 diabetes. By taking part, volunteers can help scientists understand whether this new combination of tablets could offer an effective new tool for kidney care in the future.
Key takeaways
- ASPIRE-1 tests whether combining two medicines protects kidney health in type 1 diabetes.
- Open to adults aged 18 and over with both type 1 diabetes and kidney disease.
- Participants will test different treatments at different times during the study.
- Regular health checks, blood tests, and urine tests will monitor your safety.
- Taking part is completely voluntary and you can stop at any time.
Who may be eligible?
This clinical trial is designed for adults aged 18 and over who have been diagnosed with both type 1 diabetes and chronic kidney disease. Men and women are equally welcome to join.
To take part, your kidneys must show signs of mild-to-moderate strain, usually measured by protein in your urine or changes in your routine blood test results. Your diabetes and blood pressure should also be reasonably stable before starting the trial.
You might not be eligible if you have type 2 diabetes, very severe kidney failure needing immediate dialysis, recent serious heart problems, or if you are pregnant or breastfeeding. The study team will run simple blood and urine tests with you first to make sure it is completely safe for you to join.
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 at least 18 years old.
- I have been diagnosed with type 1 diabetes.
- My doctor has told me I have chronic kidney disease or protein in my urine.
- I am able to attend regular clinic appointments for health checks.
- I am not currently pregnant or planning a pregnancy during the study.
What does participation involve?
If you take part in ASPIRE-1, you will be invited to a local hospital or research clinic for regular check-ups. Because this is a cross-over trial, you will receive different treatment stages during the study. At certain times, you might take one tablet alone, and at other times, you might take both tablets together. You may also have short rest periods (called 'washout' periods) between stages.
During your visits, the research team will check your blood pressure, weigh you, and collect blood and urine samples. These checks help monitor your kidney health and ensure your body is not holding on to extra fluid. You will continue taking your normal daily insulin alongside the study tablets.
The trial team will explain the exact number of hospital visits and the total length of the study before you agree to join. Travel expenses for your study appointments are typically covered.
Potential risks and benefits
Locations (2)
- —UnverifiedFinland
- —UnverifiedDenmark
Common questions
What is a cross-over trial?
A cross-over trial means each participant gets to test more than one treatment option at different times, rather than only being assigned to a single group.
Do I need to stop taking my usual insulin?
No. You will continue your daily insulin therapy just as you normally do, under the guidance of your diabetes care team.
What is UACR?
UACR stands for Urine Albumin-to-Creatinine Ratio. It is a simple urine test that checks how much protein is leaking through your kidney filters.
Will taking part cost me anything?
No. The study medication and extra tests are provided free of charge, and travel expenses to the clinic are usually reimbursed.
Can I leave the study if I feel unwell?
Yes. You can leave the study at any point without giving a reason, and your standard NHS medical treatment will not be affected.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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