Status:
ACTIVE_NOT_RECRUITING
Efficacy of Dapagliflozin in Early Diabetic Nephropathy in Type 1 Diabetes
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Conditions:
Diabetic Kidney Disease
Type 1 Diabetes
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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 standa...
Detailed Description
This is an open-label, randomized, parallel-group study to evaluate the effects of dapagliflozin on urinary albumin/creatinine ratio (UACR) in participants with early diabetic nephropathy and type 1 d...
Eligibility Criteria
Inclusion
- Age between 18 and 65 years;
- Diagnosed with type 1 diabetes mellitus with a disease duration of more than 5 years;
- Glycated hemoglobin (HbA1c) ≤ 7.5% at screening;
- Diagnosed with diabetic nephropathy;
- UACR between 30 and 300 and eGFR ≥ 60 ml/min/1.73 m².
Exclusion
- Other types of diabetes;
- Use of any antidiabetic medications (excluding insulin) within 1 month prior to screening;
- History of diabetic ketoacidosis within 3 months prior to screening, or a diagnosed episode of diabetic ketoacidosis within the past 1 month;
- History of poor blood glucose control requiring hospitalization (due to hyperglycemia or hypoglycemia) within 1 month prior to screening;
- Frequent severe hypoglycemia or unconscious hypoglycemia (more than once requiring medical intervention or emergency care) within 1 month prior to screening;
- Use of SGLT2 inhibitors or other renal protective medications within 6 months prior to screening;
- Women who are planning to become pregnant, pregnant, or breastfeeding;
- Cardiovascular disease (within 6 months prior to screening);
- Unstable/rapidly progressing renal disease (within 6 months prior to screening), or renal artery stenosis;
- Major liver disease or malignant tumors (within 5 years prior to screening).
Key Trial Info
Start Date :
July 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2026
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT06532682
Start Date
July 1 2024
End Date
October 1 2026
Last Update
August 1 2024
Active Locations (1)
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1
Nanjing Medical University First Affiliated Hospital
Nanjing, Jiangsu, China, 210000