Trial of Semaglutide for Diabetic Kidney Disease in Type 1 Diabetes
NCT ID: NCT05822609
Last Updated: 2025-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
60 participants
INTERVENTIONAL
2024-04-05
2026-06-30
Brief Summary
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Detailed Description
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Study Aims and Hypotheses:
Aim 1: Determine the effects of semaglutide vs. placebo on kidney oxygenation in type 1 diabetes. Hypothesis 1: Semaglutide will improve kidney oxygen availability in adults with type 1 diabetes.
Aim 2: Determine the effects of semaglutide vs. placebo on urine albumin-creatinine ratio and estimated glomerular filtration rate in type 1 diabetes. Hypothesis 2: Semaglutide will lower albuminuria and slow estimated glomerular filtration rate decline in adults with type 1 diabetes.
Aim 3: Determine the glycemic effects and safety of semaglutide vs. placebo in type 1 diabetes. Hypothesis 3: Semaglutide will reduce total daily insulin dose and improve glycemic variability without increasing risk of severe hypoglycemia or diabetic ketoacidosis in adults with type 1 diabetes.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Semaglutide
Semaglutide group from 0.25mg to 1.0mg
Semaglutide
1.0 mg
Placebo
Placebo group
Placebo
Placebo
Interventions
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Semaglutide
1.0 mg
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* Diabetes duration of ≥5 years
* Persistent urine albumin-to-creatinine ratio (UACR) ≥ 30 mg/g, on the most recent two measurements within the prior 3 years
* Estimated glomerular filtration rate ≥ 30 mL/min/1.73m2
* Stable doses of drugs altering blood pressure (e.g., Angiotensin-converting enzyme inhibitor) required for at least 4 weeks prior to randomization, and requested for the duration of the trial
* Stable doses of lipid-lowering medications required for at least 4 weeks prior to randomization, and requested for the duration of the trial
* Adequate contraceptive method for females of child-bearing potential
Exclusion Criteria
* Other causes of diabetes mellitus, including type 2 diabetes and maturity-onset diabetes of the young (MODY)
* Chronic kidney disease unrelated to diabetes
* Personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) or thyroid nodule palpated by endocrinologist at screening
* Personal history of pancreatitis
* Current/planned pregnancy or nursing
* Uncontrolled thyroid disease or hypertension (Systolic blood pressure \[SBP\] ≥ 160 mm Hg or diastolic blood pressure \[DBP\] ≥ 100 mm Hg despite treatment)
* Proliferative retinopathy with treatment in the past 6 months
* Uncontrolled or potentially unstable diabetic retinopathy or maculopathy, verified by fundus examination with pupil dilation unless performed using a digital fundus photography camera specified for non-dilated examination
* More than 2 severe hypoglycemic episodes (requiring glucagon and/or assistance from another person) 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%)
* Pramlintide and the use of glycemia treatments not approved for type 1 diabetes by the FDA, e.g., metformin, SGT-2 inhibitor, GLP-1 receptor agonist, closed loop insulin delivery using unapproved algorithms
* Significant systemic conditions or treatment such as cancer or immunomodulators
* Known liver disease other than non-alcoholic fatty liver disease (NAFLD) or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>100 IU/L, history of severe gastrointestinal disease (e.g., gastroparesis) or gallstones
* Body mass index \<20 kg/m2
* Inability to cooperate with or clinical contraindication for magnetic resonance imaging including severe claustrophobia, nonremovable devices, implanted metal
* Known or suspected allergy/sensitivity to semaglutide or its excipients
* Pregnant, breast feeding, or the intention of becoming pregnant
* The receipt of any investigational drug within 3 months prior to this trial
* Previously randomized in this trial
18 Years
ALL
No
Sponsors
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Juvenile Diabetes Research Foundation
OTHER
University of Colorado, Denver
OTHER
Providence Healthcare
OTHER
University of Toronto
OTHER
University of Washington
OTHER
Responsible Party
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Ian deBoer
Professor, School of Medicine
Principal Investigators
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Ian de Boer, MD, MS
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Jessica Kendrick, MD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado Anschutz Medical Campus and Children's Hospital Colorado
David Cherney, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
University of Toronto
Irl Hirsch, MD
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Katherine Tuttle, MD
Role: PRINCIPAL_INVESTIGATOR
Providence Healthcare
Locations
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University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
University of Washington
Seattle, Washington, United States
Providence Sacred Heart Medical Center
Spokane, Washington, United States
Toronto General Hospital, University Health Network
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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Kugathasan L, Aronson Y, Sridhar VS, Ni H, Ouimet JP, Limonte CP, Sarma S, Cherney DZI. Advancing kidney protection in type 1 diabetes: insights from emerging therapies in type 2 diabetes and chronic kidney disease. Expert Rev Clin Immunol. 2025 Aug;21(8):1113-1134. doi: 10.1080/1744666X.2025.2537446. Epub 2025 Jul 24.
Other Identifiers
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STUDY00016349
Identifier Type: -
Identifier Source: org_study_id
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