Actively Recruiting
Trial of Semaglutide for Diabetic Kidney Disease in Type 1 Diabetes
Led by University of Washington · Updated on 2025-08-28
60
Participants Needed
4
Research Sites
112 weeks
Total Duration
On this page
Sponsors
U
University of Washington
Lead Sponsor
J
Juvenile Diabetes Research Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
The primary objective of this study is to determine the effects of semaglutide on kidney oxygenation and function in type 1 diabetes. The secondary objective is to determine the glycemic effects and safety of semaglutide in type 1 diabetes.
CONDITIONS
Official Title
Trial of Semaglutide for Diabetic Kidney Disease in Type 1 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults (≥18 years) with type 1 diabetes
- Diabetes duration of 5 years or more
- Persistent urine albumin-to-creatinine ratio (UACR) of 30 mg/g or higher on the most recent two measurements within the prior 3 years
- Estimated glomerular filtration rate of 30 mL/min/1.73m2 or higher
- Stable doses of blood pressure medications (e.g., ACE inhibitors) for at least 4 weeks before randomization and during the trial
- Stable doses of lipid-lowering medications for at least 4 weeks before randomization and during the trial
- Adequate contraception for females who can become pregnant
You will not qualify if you...
- HbA1c greater than 9%, recent diabetic ketoacidosis, hyperosmolar hyperglycemic state, or severe illness requiring hospitalization in the past 30 days
- Other types of diabetes such as type 2 diabetes or maturity-onset diabetes of the young (MODY)
- Chronic kidney disease not related to diabetes
- Personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2), or thyroid nodule found by endocrinologist at screening
- Personal history of pancreatitis
- Current or planned pregnancy or breastfeeding
- Uncontrolled thyroid disease or high blood pressure (SBP ≥ 160 mm Hg or DBP ≥ 100 mm Hg despite treatment)
- Proliferative retinopathy treated in the past 6 months
- Uncontrolled or unstable diabetic retinopathy or maculopathy
- More than 2 severe hypoglycemic episodes requiring help in the past 6 months
- Frequent hypoglycemia during the last two weeks of the study run-in phase (time below range <70 mg/dL ≥4%)
- Use of pramlintide or glycemia treatments not approved for type 1 diabetes by the FDA (e.g., metformin, SGLT-2 inhibitors, GLP-1 receptor agonists, unapproved closed loop insulin delivery)
- Significant systemic conditions or treatments such as cancer or immunomodulators
- Known liver disease other than non-alcoholic fatty liver disease (NAFLD) or elevated liver enzymes (AST or ALT >100 IU/L), history of severe gastrointestinal disease or gallstones
- Body mass index less than 20 kg/m2
- Inability to undergo MRI due to claustrophobia or implanted metal devices
- Known or suspected allergy to semaglutide or its ingredients
- Pregnant, breastfeeding, or planning pregnancy
- Received any investigational drug within 3 months prior to this trial
- Previously enrolled in this trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
2
University of Washington
Seattle, Washington, United States, 98104
Actively Recruiting
3
Providence Sacred Heart Medical Center
Spokane, Washington, United States, 99204
Actively Recruiting
4
Toronto General Hospital, University Health Network
Toronto, Ontario, Canada, M5G2N2
Actively Recruiting
Research Team
E
Ernest Ayers, MSPH
CONTACT
L
Leila Zelnick, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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