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dApagliflozin SC0062 and Prevention of Renal Injury; a Randomized Evaluation

NCT06072326 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-10-07

No results posted yet for this study

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.

Conditions

  • Type 1 Diabetes Mellitus With Diabetic Nephropathy

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

Sponsors & Collaborators

  • Juvenile Diabetes Research Foundation

    collaborator OTHER

  • Biocity Biopharmaceutics Co., Ltd.

    collaborator INDUSTRY

  • University Medical Center Groningen

    lead OTHER

Principal Investigators

  • Hiddo J Lambers Heerspink, PhD, PharmD · University Medical Center Groningen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2027-12-31
Completion
2028-12-31

Countries

  • Denmark
  • Finland
  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06072326 on ClinicalTrials.gov