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 groupsSponsors 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