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NOT YET RECRUITING
NCT06072326
PHASE2

dApagliflozin SC0062 and Prevention of Renal Injury; a Randomized Evaluation

Sponsor: University Medical Center Groningen

View on ClinicalTrials.gov

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

DRUG

Dapagliflozin (Forxiga®)

5 mg/day as a tablet

DRUG

SC0062 strength 10mg

20 mg/day, twice daily, capsule

DRUG

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