Not yet recruitingPHASE2INTERVENTIONAL

Prevention of Chronic Kidney Disease(CDK) Progression in Type 1 Diabetes With Long Term Use of Sodium-Glucose-coTransporter Inhibitors Avoiding Kidney hypOxia

This research is investigating a medication called sotagliflozin in people with type 1 diabetes who also have kidney problems. Previous studies in type 2 diabetes showed similar drugs could help protect the heart and kidneys, and this trial aims to see if the same is true for type 1 diabetes. Specifically, the study wants to understand how sotagliflozin affects the oxygen levels in the kidneys over 12 weeks. Researchers will also look at heart function and other health markers in blood and urine. The goal is to find new ways to prevent kidney disease from worsening in people with type 1 diabetes.

At a glance

Status

Not yet recruiting

Phase

PHASE2

Sponsor

Steno Diabetes Center Copenhagen

Enrolment target

Start

01 Feb 2025

Estimated completion

01 May 2027

Nephropathy Diabetic Nephropathies Diabetes Mellitus, Type 1 Albuminuria Diabetic Complications Renal Diabetic Complications Cardiovascular Hypoxia

What is this study about?

This study is about understanding how a new type of treatment, called sotagliflozin, could help people with type 1 diabetes who are also experiencing kidney problems. People with type 1 diabetes are at a higher risk of developing issues with their kidneys and heart over time. Similar medications have shown promise in protecting the heart and kidneys in individuals with type 2 diabetes, but we need to see if they can do the same for those with type 1 diabetes.

The main goal is to find out if taking sotagliflozin for 12 weeks can improve how much oxygen your kidneys are getting. We don't fully understand why these drugs help the kidneys, but changes in kidney oxygen might be part of the explanation. The study will also look at how this treatment might affect your heart health and other important markers in your blood and urine that tell us about your kidney function.

By carefully studying these effects, we hope to discover new and better ways to slow down or even stop kidney disease from getting worse in people living with type 1 diabetes. This could lead to better health and quality of life for many individuals.

Key takeaways

This study investigates a new drug for kidney protection in type 1 diabetes.
It aims to understand how the drug affects oxygen levels in the kidneys.
Participation involves taking either the study drug or a placebo, changing after a break.
You will have regular clinic visits, blood/urine tests, and MRI scans.
The study compares effects in people of different ancestries.
It's a 'double-blind' study, meaning neither you nor the doctors will know which treatment you're on.

Who may be eligible?

To join this study, you need to be at least 18 years old and have type 1 diabetes that started before you were 40. You also need to have certain signs of kidney disease, specifically a specific amount of protein in your urine (called albuminuria) and your kidney function (eGFR) should be within a particular range, not too good, and not too bad. You should also be taking stable medication to protect your kidneys, known as RAS blockers, for at least 4 weeks before the study starts and continue throughout the study.

There are several reasons why you might not be able to join. For example, if your kidney disease is caused by something other than diabetes, or if your kidney function is very low (eGFR below 25), or if you are on dialysis or have had a kidney transplant. You also can't participate if you've recently had a severe episode of diabetic ketoacidosis, have poorly controlled diabetes (HbA1c too high), are pregnant, breastfeeding, or planning to become pregnant. If you've recently taken a similar drug (SGLT inhibitor), had certain heart problems, or can't undergo an MRI scan, you would also be excluded.

Quick self-check

Are you 18 years or older and have type 1 diabetes?
Do you have signs of kidney disease, like protein in your urine (albuminuria)?
Are your kidneys working within a specific range (eGFR between 25 and 75)?
Are you taking stable medication to protect your kidneys (RAS blockers)?
Are you able to have an MRI scan (e.g., no metal implants)?
Are you not pregnant, breastfeeding, or planning a pregnancy soon?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you'll be assigned to either receive the study drug, sotagliflozin, or a placebo (a dummy pill with no active medicine) for 12 weeks. You won't know which one you're taking, and neither will the study team. After a break, you'll then switch to the other treatment for another 12 weeks. This is called a 'crossover' design.

Throughout the study, you'll have several visits to the clinic for assessments. These will include regular blood and urine tests to check your kidney function and other health markers. A key part of the study involves special MRI scans to measure the oxygen levels and blood flow in your kidneys, as well as checking your heart function. You'll need to be able to lie still for these scans. The study is planned to start inviting patients from February 2024, with the last patient visits expected by September 2025. Results are aimed for presentation in Spring 2026 and publication in Fall 2026.

Potential risks and benefits

Taking part in this study could potentially offer benefits by contributing to our understanding of how to better manage kidney disease in type 1 diabetes, which might ultimately lead to new treatments. You would also receive close medical monitoring throughout the study. However, like all medications, sotagliflozin may have side effects, and some tests, like MRI, have their own requirements. The specific risks will be fully explained to you before you agree to participate. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

Steno Diabetes Center Copenhagen
Herlev, Denmark
Guy's and St Thomas NHS Trust
London, United Kingdom

Common questions

What is type 1 diabetes?

Type 1 diabetes is a condition where your body's immune system mistakenly attacks and destroys the cells in your pancreas that produce insulin, a hormone essential for controlling blood sugar.

What is 'kidney problems' in this context?

In this study, 'kidney problems' refers to diabetic kidney disease, often indicated by protein leaking into the urine (albuminuria) and changes in how well your kidneys are filtering waste from your blood.

What is an SGLT inhibitor?

SGLT inhibitors are a type of medication that helps your body remove excess sugar through your urine. They're also thought to have protective effects on the kidneys and heart.

Will I know if I'm taking the real drug or a dummy pill?

No, this is a 'double-blind' study, meaning neither you nor the study team will know if you're receiving the active drug or the placebo during the treatment periods.

What is an MRI scan?

An MRI (Magnetic Resonance Imaging) is a type of scan that uses strong magnets and radio waves to create detailed pictures of organs and structures inside your body, without using X-rays.

How to find out more

Mette Brouw Iversen, MD

mette.brouw.iversen@regionh.dk +4529267717 Official trial record

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