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 range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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