dApagliflozin SC0062 and Prevention of Renal Injury; a Randomized Evaluation

Sponsor
University Medical Center Groningen
Study ID
NCT06072326
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Type 1 Diabetes Mellitus With Diabetic Nephropathy

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin (Forxiga®) — DRUG
    5 mg/day as a tablet
  • SC0062 strength 10mg — DRUG
    20 mg/day, twice daily, capsule
  • SC0062 and dapagliflozin — DRUG
    20 mg/day SC0062 10 mg twice daily as a capsule in combination with 5 mg/day dapagliflozin 5 mg as a tablet

Study Details

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.

Key Dates

Start date
Jan 31, 2026
Status verified
Oct 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment order 1
    Subjects will start with 4 weeks of SC0062 in treatment period 1. In period 2 subjects will receive dapagliflozin. In period 3 subjects will receive a combination of SC0062 and dapagliflozin. Between treatment periods there is a 4-week wash-out.
  • Experimental: Treatment order 2
    Subjects will start with 4 weeks of SC0062 in treatment period 1. In period 2 subjects will receive a combination of SC0062 and dapagliflozin. In period 3 subjects will receive dapagliflozin. Between treatment periods there is a 4-week wash-out.
  • Experimental: Treatment order 3
    Subjects will start with 4 weeks of dapagliflozin in treatment period 1. In period 2 subjects will receive a combination of SC0062 and dapagliflozin. In period 3 subjects will receive SC0062. Between treatment periods there is a 4-week wash-out.
  • Experimental: Treatment order 4
    Subjects will start with 4 weeks of dapagliflozin in treatment period 1. In period 2 subjects will receive SC0062. In period 3 subjects will receive a combination of SC0062 and dapagliflozin. Between treatment periods there is a 4-week wash-out.
  • Experimental: Treatment order 5
    Subjects will start with 4 weeks of a combination of SC0062 and dapagliflozin in period 1. In period 2 subjects will receive SC0062. In period 3 subjects will receive dapagliflozin. Between treatment periods there is a 4-week wash-out.
  • Experimental: Treatment order 6
    Subjects will start with 4 weeks of a combination of SC0062 and dapagliflozin in period 1. In period 2 subjects will receive dapagliflozin. In period 3 subjects will receive SC0062. Between treatment periods there is a 4-week wash-out.

Primary Outcome Measure

Change from baseline in Urine Albumin-Creatinine Ratio (UACR) [ Time Frame: 4 weeks ]

Central Contacts