Diabetic Kidney DiseasePhase 4NCT06532682
Efficacy of Dapagliflozin in Early Diabetic Nephropathy in Type 1 Diabetes
A Phase 4 study testing dapagliflozin and ACE inhibitor in people with Diabetic Kidney Disease and Type 1 Diabetes, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetic Kidney Disease, Type 1 Diabetes
- What is being tested?
- dapagliflozin and ACE inhibitor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2024to 1 Oct 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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).
Trial locations and contacts
1 site in 1 country.
China1 site
Nanjing Medical University First Affiliated Hospital
Nanjing, Jiangsu, 210000
About this study
Official title: Efficacy and Mechanism of Dapagliflozin Combined With Insulin in the Treatment of Early Diabetic Nephropathy in Patients With Type 1 Diabetes
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.
Read the 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 treatment in these patients. Secondary objectives include observing blood glucose control, weight improvement, and safety evaluation after dapagliflozin treatment.
The study comprises three groups: dapagliflozin 10 mg, dapagliflozin 5 mg, and a standard treatment control, with a 1:1:1 allocation ratio. Participants meeting the inclusion criteria and not meeting any exclusion criteria will enter a 4-8 week lead-in period, during which they will receive the maximum tolerable dose of ACEI/ARB medications, maintain this treatment for at least 4 weeks, and optimize blood glucose control under the guidance of medical professionals while wearing continuous glucose monitoring devices. Starting from baseline, participants will receive either dapagliflozin 5 mg or 10 mg once daily for 24 weeks, while the control group will continue on the maximum tolerable dose of ACEI/ARB medications. Continuous glucose monitoring and regular ketone monitoring will be performed to prevent diabetic ketoacidosis. Follow-up visits will occur approximately 30 days after the last dose of study medication or upon study completion.
The primary efficacy indicators are the mean changes in UACR and eGFR from baseline to week 24. Secondary efficacy indicators include changes in 24-hour urine biochemistry, HbA1c, body weight, continuous glucose monitoring indices, and total daily insulin dose. Safety evaluation indicators include adverse events, serious adverse events, diabetic ketoacidosis, severe hypoglycemia, and urinary or genital infections.
- Conditions
- Diabetic Kidney Disease, Type 1 Diabetes
- Being tested
- dapagliflozin, ACE inhibitor
- Medical subject headings
- Diabetic Nephropathies, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dapagliflozinDrug
Also called Farxiga
dapagliflozin 5 MG/10 MG once daily
ACE inhibitorDrug
ACE inhibitor
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: ACE inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary albumin-to-creatinine ratio
Average change from baseline to 24 weeks after treatment
Measured: From baseline to 24 weeks
estimated Glomerular Filtration Rate
Average change from baseline to 24 weeks after treatment
Measured: From baseline to 24 weeks
Secondary outcomes (5)
24-hour urine biochemical quantification
Average change from baseline to 24 weeks after treatment
Measured: From baseline to 24 weeks
HbA1c
Change from baseline to 24 weeks after treatment
Measured: From baseline to 24 weeks
Weight
Change from baseline to 24 weeks after treatment
Measured: From baseline to 24 weeks
Time in Range
Evaluate blood glucose control through continuous glucose monitoring
Measured: From baseline to 24 weeks
Daily insulin dose
Change from baseline to 24 weeks after treatment
Measured: From baseline to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start1 Jul 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mei Zhang, Principal investigator, Nanjing Medical University First Affiliated Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06532682
- Sponsor's protocol ID
- 2023-SR-929
- Status last verified
- Jul 2024
- First submitted
- 23 Jul 2024
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Mechanism of Dapagliflozin Combined With Insulin in the Treatment of Early Diabetic Nephropathy in Patients With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT06532682
- Acronym / sponsor ID
- 2023-SR-929
- Conditions
- Diabetic Kidney Disease, Type 1 Diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (actual)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 1 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 treatment in these patients. Secondary objectives include observing blood glucose control, weight improvement, and safety evaluation after dapagliflozin treatment.
The study comprises three groups: dapagliflozin 10 mg, dapagliflozin 5 mg, and a standard treatment control, with a 1:1:1 allocation ratio. Participants meeting the inclusion criteria and not meeting any exclusion criteria will enter a 4-8 week lead-in period, during which they will receive the maximum tolerable dose of ACEI/ARB medications, maintain this treatment for at least 4 weeks, and optimize blood glucose control under the guidance of medical professionals while wearing continuous glucose monitoring devices. Starting from baseline, participants will receive either dapagliflozin 5 mg or 10 mg once daily for 24 weeks, while the control group will continue on the maximum tolerable dose of ACEI/ARB medications. Continuous glucose monitoring and regular ketone monitoring will be performed to prevent diabetic ketoacidosis. Follow-up visits will occur approximately 30 days after the last dose of study medication or upon study completion.
The primary efficacy indicators are the mean changes in UACR and eGFR from baseline to week 24. Secondary efficacy indicators include changes in 24-hour urine biochemistry, HbA1c, body weight, continuous glucose monitoring indices, and total daily insulin dose. Safety evaluation indicators include adverse events, serious adverse events, diabetic ketoacidosis, severe hypoglycemia, and urinary or genital infections.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Drug: Dapagliflozin 10 MG + ACE inhibitor | Experimental | Drug: dapagliflozin, Drug: ACE inhibitorUsing 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 | Experimental | Drug: dapagliflozin, Drug: ACE inhibitorUsing 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 | Active comparator | Drug: ACE inhibitorUsing ACE inhibitors/ARBs as standard treatment for a total treatment duration of 24 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dapagliflozinAlso: Farxigadapagliflozin 5 MG/10 MG once daily | Drug | Drug: Dapagliflozin 10 MG + ACE inhibitor, Drug: Dapagliflozin 5 MG + ACE inhibitor |
| ACE inhibitorACE inhibitor | Drug | Drug: ACE inhibitor, Drug: Dapagliflozin 10 MG + ACE inhibitor, Drug: Dapagliflozin 5 MG + ACE inhibitor |
Primary outcome
Urinary albumin-to-creatinine ratio
Time frame: From baseline to 24 weeks
Average change from baseline to 24 weeks after treatment
estimated Glomerular Filtration Rate
Time frame: From baseline to 24 weeks
Average change from baseline to 24 weeks after treatment
5 secondary outcomes
24-hour urine biochemical quantification
Time frame: From baseline to 24 weeks
HbA1c
Time frame: From baseline to 24 weeks
Weight
Time frame: From baseline to 24 weeks
Time in Range
Time frame: From baseline to 24 weeks
Daily insulin dose
Time frame: From baseline to 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Individual participant dataSharing planned: No
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Pentoxifylline in Diabetic Kidney Disease
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A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mei Zhang principal investigator
Nanjing Medical University First Affiliated Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing dapagliflozin and ACE inhibitor in people with Diabetic Kidney Disease and Type 1 Diabetes, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary albumin-to-creatinine ratio (time frame: From baseline to 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2024.