Efficacy of Dapagliflozin in Early Diabetic Nephropathy in Type 1 Diabetes

NCT06532682 | Active Not Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 2023-SR-929
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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 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

Outcome Measures

Primary Outcomes (2)

• Urinary albumin-to-creatinine ratio

  Average change from baseline to 24 weeks after treatment

  From baseline to 24 weeks

• estimated Glomerular Filtration Rate

  Average change from baseline to 24 weeks after treatment

  From baseline to 24 weeks

Secondary Outcomes (5)

• 24-hour urine biochemical quantification

  From baseline to 24 weeks

• HbA1c

  From baseline to 24 weeks

• Weight

  From baseline to 24 weeks

• Time in Range

  From baseline to 24 weeks

• Daily insulin dose

  From baseline to 24 weeks

Study Arms (3)

Drug: Dapagliflozin 10 MG + ACE inhibitor

EXPERIMENTAL

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; Drug: ACE inhibitor

Drug: Dapagliflozin 5 MG + ACE inhibitor

EXPERIMENTAL

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: dapagliflozin; Drug: ACE inhibitor

Drug: ACE inhibitor

ACTIVE COMPARATOR

Using ACE inhibitors/ARBs as standard treatment for a total treatment duration of 24 weeks.

Drug: ACE inhibitor

Interventions

dapagliflozin DRUG

dapagliflozin 5 MG/10 MG once daily

Also known as: Farxiga

Drug: Dapagliflozin 10 MG + ACE inhibitor; Drug: Dapagliflozin 5 MG + ACE inhibitor

ACE inhibitor DRUG

ACE inhibitor

Drug: ACE inhibitor; Drug: Dapagliflozin 10 MG + ACE inhibitor; Drug: Dapagliflozin 5 MG + ACE inhibitor

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

Nanjing Medical University First Affiliated Hospital

Nanjing, Jiangsu, 210000, China

Location

MeSH Terms

Conditions

Diabetic Nephropathies; Diabetes Mellitus, Type 1

Interventions

dapagliflozin; Angiotensin-Converting Enzyme Inhibitors

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Mei Zhang

  Nanjing Medical University First Affiliated Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2024
• First Posted: August 1, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)