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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Semaglutide
Drug1.0 mg
Placebo
Other interventionPlacebo
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: SemaglutideExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in urine albumin excretion
Measured as mean of multiple urine albumin-creatinine ratio measurements in spot urine
Time frame
Baseline to 26 weeksSecondary outcomes
1
Change in kidney cortical relaxation rates (R2*)
Measurement of oxygenation by magnetic resonace imaging
Time frame
Baseline to 26 weeks2
Change in estimated glomerular filtration rate
Estimated glomerular filtration rate will be calculated from age, sex, and the serum concentrations of creatinine and cystatin C
Time frame
Baseline to 26 weeks3
Change in glucose time in range
Proportion of time with glucose 70-180 mg/dL measured by continuous glucose monitoring
Time frame
Baseline to 26 weeks4
Change in glucose coefficient of variation
Measured by continuous glucose monitoring
Time frame
Baseline to 26 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
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