Trial of Semaglutide for Diabetic Kidney Disease in Type 1 Diabetes
University of Washington
Summary
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.
Description
A parallel-group, double-blind, placebo-controlled, randomized study will rigorously test effects of semaglutide on the kidney. Real-time continuous glucose monitoring will be used to control glycemia during study run-in (prior to randomization) and during active therapy, which investigators anticipate will lead to similar glycemic control according to treatment assignment and ability to assess effects independent of glycemia. The trial duration is 26 weeks, a period of time sufficient to gradually titrate study medications to maximum target dose (over 12 weeks) and then observe the full short…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 ≥ 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 durati…
Interventions
- DrugSemaglutide
1.0 mg
- OtherPlacebo
Placebo
Locations (4)
- University of Colorado Anschutz Medical CampusAurora, Colorado
- University of WashingtonSeattle, Washington
- Providence Sacred Heart Medical CenterSpokane, Washington
- Toronto General Hospital, University Health NetworkToronto, Ontario