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dApagliflozin SC0062 and Prevention of Renal Injury; a Randomized Evaluation
Sponsor: University Medical Center Groningen
Summary
The aim of this study is to test the hypothesis that dapagliflozin (SGLT2 inhibitor) and SC0062 (ERA) combination therapy augments nephroprotection and mitigates fluid retention and ketogenesis in people with T1D through complementary and synergistic mechanisms of actions.
Official title: Individual and Combined Endothelin Receptor and SGLT2 Antagonism in Adults With Type 1 Diabetes Mellitus and Chronic Kidney Disease: a Phase 2, Multicenter, Open-label Randomized Cross-over Trial
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
36
Start Date
2026-01
Completion Date
2028-12
Last Updated
2025-10-07
Healthy Volunteers
No
Interventions
Dapagliflozin (Forxiga®)
5 mg/day as a tablet
SC0062 strength 10mg
20 mg/day, twice daily, capsule
SC0062 and dapagliflozin
20 mg/day SC0062 10 mg twice daily as a capsule in combination with 5 mg/day dapagliflozin 5 mg as a tablet
Locations (7)
Steno Diabetes Center Aarhus
Aarhus, Denmark
Steno Diabetes Center Copenhagen
Copenhagen, Denmark
Regionshospitalet Gødstrup
Herning, Denmark
University of Helsinki
Helsinki, Uusimaa, Finland
Turku University Hospital
Turku, Finland
Amsterdam University Academic Center
Amsterdam, North Holland, Netherlands
University Medical Center Groningen
Groningen, Provincie Groningen, Netherlands