Trial of Semaglutide for Diabetic Kidney Disease in Type 1 Diabetes
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Washington
About this trial
The primary objective of this study is to determine the effects of semaglutide on change in albuminuria from baseline to 26 weeks in type 1 diabetes. The secondary objective is to determine the effects of semaglutide on change in kidney parameters (including kidney oxygenation and function) measured by MRI from baseline to 26 weeks in type 1 diabetes. Other objectives are to determine the glycemic effects and safety of semaglutide in type 1 diabetes.
Eligibility criteria
Qualifiers
Adults (≥18 years) with type 1 diabetes
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 ≥ 20 mL/min/1.73m2
Disqualifiers
HbA1c >9%, recent diabetic ketoacidosis, hyperosmolar hyperglycemic state or severe illness requiring hospitalization in past 30 days
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
Trial design
Treatments tested in this trial
- Semaglutide
- Placebo
Treatment groups
60 Participants
are divided into 2 treatment groupsLocations
4Canada
Toronto General Hospital, University Health NetworkM5G2N2, TorontoOntario, Canada
United States
University of Colorado Anschutz Medical Campus80045, AuroraColorado, United States
University of Washington98104, SeattleWashington, United States
Providence Sacred Heart Medical Center99204, SpokaneWashington, United States
Sponsors and collaborators
University of Washington
Lead sponsor
Juvenile Diabetes Research Foundation
Collaborator
University of Colorado, Denver
Collaborator
Providence Healthcare
Collaborator
University of Toronto
Collaborator
Source ClinicalTrials.gov