Semaglutide for Diabetic Kidney Disease in Type 1 Diabetes
(RT1D Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how semaglutide affects kidney health and blood sugar control in people with type 1 diabetes. Researchers aim to determine if this treatment can improve kidney function and oxygen levels while remaining safe and effective for diabetes management. Participants will receive either semaglutide (a medication for managing blood sugar levels) or a placebo (a harmless pill with no active medicine) to compare results. The trial seeks adults who have had type 1 diabetes for at least 5 years and experience certain kidney-related issues, such as elevated protein levels in their urine. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in diabetes care.
Will I have to stop taking my current medications?
The trial requires that you stay on stable doses of blood pressure and lipid-lowering medications for at least 4 weeks before starting and throughout the trial. Other medications, especially those not approved for type 1 diabetes, may need to be stopped.
Is there any evidence suggesting that semaglutide is likely to be safe for humans?
Research has shown that semaglutide is generally well-tolerated. In one study, fewer participants taking semaglutide experienced serious side effects compared to those on a placebo (49.6% vs. 53.8%). This finding suggests semaglutide might be safer than not taking it. Additionally, semaglutide is already approved for other conditions, which supports its safety profile. While this trial continues to gather more data, current evidence indicates that semaglutide is a safe option for further study in individuals with type 1 diabetes.12345
Why do researchers think this study treatment might be promising for diabetic kidney disease?
Researchers are excited about semaglutide for diabetic kidney disease in Type 1 diabetes because it offers a new approach beyond the standard care of blood pressure control and glucose management. Semaglutide is a GLP-1 receptor agonist, which not only helps in controlling blood sugar levels but also has potential kidney-protective effects by reducing inflammation and oxidative stress in the kidneys. This dual action makes semaglutide particularly promising, as it could slow the progression of kidney damage while simultaneously managing diabetes.
What evidence suggests that semaglutide might be an effective treatment for diabetic kidney disease?
Research shows that semaglutide, which participants in this trial may receive, can help improve kidney health. In past studies, semaglutide reduced the risk of kidney problems in people with type 2 diabetes and lowered the chances of heart issues and death from any cause. For people with type 1 diabetes, early research suggests semaglutide might improve kidney function and reduce protein leakage into the urine. These promising results suggest semaglutide might also effectively improve kidney health in type 1 diabetes.12345
Who Is on the Research Team?
David Cherney
Principal Investigator
University of Toronto
Irl Hirsch, MD
Principal Investigator
University of Washington
Ian de Boer, MD
Principal Investigator
University of Washington
Jessica Kendrick, MD
Principal Investigator
University of Colorado Anschutz Medical Campus and Children's Hospital Colorado
Katherine Tuttle, MD
Principal Investigator
Providence Healthcare
Are You a Good Fit for This Trial?
This trial is for adults over 18 with type 1 diabetes who have had the condition for at least five years and are showing signs of kidney disease. They must have stable blood pressure and cholesterol medication use, and women able to have children need to use birth control.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Run-in
Real-time continuous glucose monitoring is used to control glycemia prior to randomization
Treatment
Participants receive semaglutide or placebo with titration to maximum target dose over 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Placebo
- Semaglutide
Semaglutide is already approved in European Union, United States, Canada, Japan for the following indications:
- Type 2 diabetes
- Cardiovascular disease
- Obesity
- Type 2 diabetes
- Cardiovascular disease
- Obesity
- Type 2 diabetes
- Cardiovascular disease
- Obesity
- Type 2 diabetes
- Cardiovascular disease
- Obesity
- Obesity
- Type 2 diabetes
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Washington
Lead Sponsor
Juvenile Diabetes Research Foundation
Collaborator
Providence Healthcare
Collaborator
University of Toronto
Collaborator
University of Colorado, Denver
Collaborator