Phase 2Not yet recruiting
dApagliflozin SC0062 and Prevention of Renal Injury; a Randomized Evaluation (ASPIRE-1)
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
- Sponsor
- University Medical Center Groningen (Academic or other)
- Enrolment
- 36 planned
- Conditions
- Type 1 Diabetes Mellitus With Diabetic Nephropathy
- Interventions
- Dapagliflozin (Forxiga®); SC0062 strength 10mg; SC0062 and dapagliflozin
- Ages
- adults, older adults
- Registry
- NCT06072326, CTIS2023-504404-28-00, CTIS2026-525684-40-01
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Change from baseline in Urine Albumin-Creatinine Ratio (UACR)
History
Study completion expected
Primary completion expected
Started
Last registry update
Registered