Efficacy of Dapagliflozin in Early Diabetic Nephropathy in Type 1 Diabetes

Sponsor
The First Affiliated Hospital with Nanjing Medical University
Study ID
NCT06532682
Phase
PHASE4
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • dapagliflozin — DRUG
    dapagliflozin 5 MG/10 MG once daily
  • ACE inhibitor — DRUG
    ACE inhibitor

Study Details

Diabetic kidney disease (DKD) is a leading cause of chronic and end-stage kidney disease, affecting 25-40% of type 1 diabetes (T1D) patients and 5-40% of type 2 diabetes (T2D) patients. Despite standard treatments like ACE inhibitors and ARBs, many patients continue to develop DKD, indicating a need for better kidney protection. This study aims to evaluate the efficacy and safety of dapagliflozin combined with insulin in early DKD patients with T1DM, using ACEi/ARB as standard treatment, to provide new insights into kidney protection and support precision medicine goals.

Key Dates

Start date
Jul 1, 2024
Status verified
Jul 2024
Primary completion
Jun 30, 2026
Completion
Oct 1, 2026

Study Design

Enrollment
54 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Drug: Dapagliflozin 10 MG + ACE inhibitor
    Using ACE inhibitors/ARBs as standard treatment, dapagliflozin is administered at a dose of 10 mg once daily, without food restrictions, for a total treatment duration of 24 weeks.
  • Experimental: Drug: Dapagliflozin 5 MG + ACE inhibitor
    Using ACE inhibitors/ARBs as standard treatment, dapagliflozin is administered at a dose of 5 mg once daily, without food restrictions, for a total treatment duration of 24 weeks.
  • Active Comparator: Drug: ACE inhibitor
    Using ACE inhibitors/ARBs as standard treatment for a total treatment duration of 24 weeks.

Primary Outcome Measure

Urinary albumin-to-creatinine ratio [ Time Frame: From baseline to 24 weeks ]

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