NCT06072326

dApagliflozin SC0062 and Prevention of Renal Injury; a Randomized Evaluation

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: University Medical Center Groningen · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A phase 2, multicenter, randomized, open-label, cross-over trial will be conducted in male or female individuals (N=36) diagnosed with type 1 diabetes at least 6 months prior to informed consent aged between 18 and 65 years, Body Mass Index (BMI) ≥ 21 kg/m2, urinary albumin: creatinine ratio ≥ 50 mg/g and \< 3000 mg/g, eGFR \> 30 and \<90 mL/min/1.73 m2 and HbA1c \> 6.5 and \<10.5%. Patients have to be on stable RAAS inhibition for at least 4 weeks prior to screening. The study will consist of a screening visit, a 4-week run-in phase. After the run-in phase, the participant will be randomized to treatment of SC0062, dapagliflozin, or their combination in random order. The duration of each treatment period is 4 weeks with study visits scheduled at 2 and 4 weeks in each treatment period. At the end of each treatment period patients proceed to a 4 weeks wash-out phase to study off drug effects. The total duration of the study for each participant after randomization is thus 24 weeks Interventions SC0062 10mg twice daily (20mg/day); dapagliflozin 5mg once daily; combination of SC0062 10mg twice daily and dapagliflozin 5mg once daily.

Conditions

• Type 1 Diabetes Mellitus With Diabetic Nephropathy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-01-01
• Primary completion: 2027-12-01
• Completion: 2028-12-01
• First posted: 2023-10-10
• Last updated: 2025-10-07

Locations

7 sites across 3 countries: Denmark, Finland, Netherlands