Efficacy of Dapagliflozin in Early Diabetic Nephropathy in Type 1 Diabetes
NCT06532682 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 54
Last updated 2024-08-01
Summary
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.
Conditions
- Diabetic Kidney Disease
- Type 1 Diabetes
Interventions
- DRUG
-
dapagliflozin 5 MG/10 MG once daily
- DRUG
-
ACE inhibitor
ACE inhibitor
Sponsors & Collaborators
-
The First Affiliated Hospital with Nanjing Medical University
lead OTHER
Principal Investigators
-
Mei Zhang · Nanjing Medical University First Affiliated Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-07-01
- Primary Completion
- 2026-06-30
- Completion
- 2026-10-01
- FDA Drug
- Yes
Countries
- China
Study Locations
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