Efficacy of Dapagliflozin in Early Diabetic Nephropathy in Type 1 Diabetes (NCT06532682) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Efficacy of Dapagliflozin in Early Diabetic Nephropathy in Type 1 Diabetes
China54 participantsStarted 2024-07-01
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
* 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).
What they're measuring
1
Urinary albumin-to-creatinine ratio
Timeframe: From baseline to 24 weeks
2
estimated Glomerular Filtration Rate
Timeframe: From baseline to 24 weeks
Trial details
NCT IDNCT06532682
SponsorThe First Affiliated Hospital with Nanjing Medical University