RecruitingPHASE2INTERVENTIONAL

Trial of Semaglutide for Diabetic Kidney Disease in Type 1 Diabetes

This research study is investigating a drug called semaglutide for adults who have Type 1 diabetes and kidney problems (diabetic kidney disease). The main goal is to find out if semaglutide can help reduce something called albuminuria, which is a sign of kidney damage, over 26 weeks. Researchers will also use special MRI scans to see if the drug improves how well the kidneys work and how much oxygen they get. Additionally, the study will monitor how semaglutide affects blood sugar levels and if it is safe to use. Half the participants will get semaglutide, and the other half will get a placebo (a dummy drug), so scientists can accurately compare the effects. The study aims to understand if semaglutide could be a new way to protect kidneys in people with Type 1 diabetes.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

University of Washington

Enrolment target

Start

05 Apr 2024

Estimated completion

01 Dec 2027

Diabetic Kidney Disease Type 1 Diabetes

What is this study about?

This study is designed to carefully look at a medication called semaglutide and its potential benefits for people living with Type 1 diabetes who also have kidney disease. Kidneys are vital organs that filter waste from your blood, and over time, high blood sugar from diabetes can damage them, leading to diabetic kidney disease. This condition can get worse and needs careful management.

The main purpose of this research is to see if semaglutide can help protect the kidneys. Specifically, doctors are looking to see if it can reduce a marker of kidney damage called albuminuria. They will also use special MRI scans to check changes in how much oxygen your kidneys receive and how well they are working. Beyond that, the study will track how semaglutide affects your blood sugar control and whether it's a safe treatment overall.

Participants will be divided into two groups: one receiving semaglutide and the other receiving a placebo (an inactive dummy medicine). This 'double-blind' approach means neither you nor your study doctor will know which treatment you are getting. This helps make the study results as accurate as possible, ensuring any observed changes are truly due to the study medication and not other factors. The study will last 26 weeks, giving enough time to gradually increase the medication dose and observe its short-term effects on your kidneys.

Key takeaways

This study investigates semaglutide for kidney protection in Type 1 diabetes.
It aims to reduce kidney damage and improve kidney function.
Participants will receive either semaglutide or a placebo.
The study involves regular health checks and MRI scans.
It lasts 26 weeks, with careful monitoring of blood sugar and safety.
You won't know if you're on the active drug or the placebo.

Who may be eligible?

To join this study, you need to be an adult (18 years or older) with Type 1 diabetes that you've had for at least 5 years. You also need to show signs of early kidney problems, specifically a certain level of protein in your urine (called albuminuria) on at least two occasions in the last three years, and your kidneys must still be working reasonably well.

Before and during the study, it's important that any medications you take for blood pressure or cholesterol have been at a steady dose for at least four weeks. If you are a woman who can become pregnant, you'll need to use reliable birth control throughout the study. There are also specific health conditions that would prevent you from taking part, such as very high blood sugar levels recently, other types of diabetes, kidney disease caused by something other than diabetes, or a personal or family history of certain thyroid cancers or pancreas issues.

Other reasons you might not be able to join include being pregnant or breastfeeding, having untreated high blood pressure, recent severe eye problems related to diabetes, frequent severe low blood sugar episodes, or taking certain other diabetes medications.

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.

Are you 18 years or older?
Do you have Type 1 diabetes and have had it for at least 5 years?
Have you recently had protein in your urine (albuminuria) on two separate occasions?
Are you able to maintain steady doses of your blood pressure and cholesterol medicines?
Are you NOT pregnant, breastfeeding, or planning to become pregnant during the study?
Have you NOT had very high blood sugar, severe eye problems, or frequent severe low blood sugar recently?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you'll be involved for a total of 26 weeks. For the first 12 weeks, the dose of your study medication (either semaglutide or a placebo) will be slowly increased. After this, you'll continue on the full study dose to allow researchers to observe its effects.

Throughout the study, you will have regular visits to the clinic for assessments. These will include blood and urine tests to check your kidney health and blood sugar levels. You'll also have special MRI scans to look at your kidneys' oxygen levels and function. To help manage your blood sugar, you'll use continuous glucose monitoring (CGM) devices, which track your sugar levels around the clock. The research team will carefully guide you through all steps, and you'll have ongoing support.

Potential risks and benefits

Participating in this study might offer potential benefits, such as very close monitoring of your kidney health and blood sugar levels, and access to a medication that might improve your kidney function. However, as with any medication, semaglutide can have side effects, which the study team will monitor closely. You'll also receive either the active drug or a placebo, so there's no guarantee you'll get the active treatment. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (4)

University of Colorado Anschutz Medical Campus
Verified postcode
Aurora, United States· Recruiting
University of Washington
Verified postcode
Seattle, United States· Recruiting
Providence Sacred Heart Medical Center
Verified postcode
Spokane, United States· Recruiting
Toronto General Hospital, University Health Network
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is semaglutide?

Semaglutide is a medication that's already used for Type 2 diabetes and weight management. This study is exploring if it can also help people with Type 1 diabetes who have kidney problems.

What does 'diabetic kidney disease' mean?

Diabetic kidney disease means that your kidneys have been affected by your diabetes, often due to high blood sugar over time. It can lead to problems with your kidneys' ability to filter your blood properly.

What is a placebo?

A placebo is a 'dummy' drug that looks exactly like the real medication but contains no active ingredients. It's used in studies to compare the effects of the actual drug against no treatment.

Will I know if I'm getting the real drug or the placebo?

No, neither you nor your study doctor will know whether you are receiving semaglutide or the placebo. This is called a 'double-blind' study and helps ensure the results are unbiased.

How long will the study last?

If you join, your participation in the study will last for 26 weeks, which is about six months.

How to find out more

Ernest Ayers, MSPH

ayerse@uw.edu 206-685-1423 Official trial record

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