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 (ASPIRE-1)

NCT06072326 Phase 2 NOT_YET_RECRUITING

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.

Details

Lead sponsor	University Medical Center Groningen
Phase	Phase 2
Status	NOT_YET_RECRUITING
Enrolment	36
Start date	2026-01
Completion	2028-12

Conditions

• Type 1 Diabetes Mellitus With Diabetic Nephropathy

Interventions

• Dapagliflozin (Forxiga®)
• SC0062 strength 10mg
• SC0062 and dapagliflozin

Primary outcomes

• Change from baseline in Urine Albumin-Creatinine Ratio (UACR) — 4 weeks
  Primary: change from baseline in Urine Albumin-Creatinine Ratio (UACR) when treated with SC0062 alone versus combination of dapagliflozin and SC0062.

Countries

Denmark, Finland, Netherlands