Efficacy of Dapagliflozin in Early Diabetic Nephropathy in Type 1 Diabetes

Phase 4

Active, not recruiting

• Conditions: Diabetic Kidney Disease; Type 1 Diabetes
• Interventions: Drug: dapagliflozin; Drug: ACE inhibitor

• Registration Number: NCT06532682
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

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 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 t...

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 diabetes mellitus (T1DM). The primary objective is to assess the changes in UACR and estimated glomerular filtration rate (eGFR) before and after dapagliflozin t...

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Status Verified: 2024-07
• Study Start: 2024-07-01
• Study First Submitted: 2024-07-23
• Study First Submitted QC: 2024-07-31
• Last Update Submitted: 2024-07-31
• Study First Posted: 2024-08-01
• Last Update Posted: 2024-08-01
• Primary Completion: 2026-06-30
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 54

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.

Read More

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).

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Drug: Dapagliflozin 10 MG + ACE inhibitor	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.
Drug: Dapagliflozin 5 MG + ACE inhibitor	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.
Drug: ACE inhibitor	ACE inhibitor	Using ACE inhibitors/ARBs as standard treatment for a total treatment duration of 24 weeks.
Drug: Dapagliflozin 10 MG + ACE inhibitor	dapagliflozin	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.
Drug: Dapagliflozin 5 MG + ACE inhibitor	dapagliflozin	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.

Primary Outcome Measures

Name	Time	Method
estimated Glomerular Filtration Rate	From baseline to 24 weeks	Average change from baseline to 24 weeks after treatment
Urinary albumin-to-creatinine ratio	From baseline to 24 weeks	Average change from baseline to 24 weeks after treatment

Secondary Outcome Measures

Name	Time	Method
HbA1c	From baseline to 24 weeks	Change from baseline to 24 weeks after treatment
24-hour urine biochemical quantification	From baseline to 24 weeks	Average change from baseline to 24 weeks after treatment
Weight	From baseline to 24 weeks	Change from baseline to 24 weeks after treatment
Time in Range	From baseline to 24 weeks	Evaluate blood glucose control through continuous glucose monitoring
Daily insulin dose	From baseline to 24 weeks	Change from baseline to 24 weeks after treatment

Trial Locations

Locations (1)

Nanjing Medical University First Affiliated Hospital; 🇨🇳 Nanjing, Jiangsu, China