Patients with Type 2 diabetes and established CKD
Conditions
Interventions
1) Ipuragliflozin group:
Participants who are assigned to the ipragliflozin group orally receive ipragliflozin 50 mg once daily in addition to their background medical therapy for diabetes. If the per
Sponsors
Node Koichi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults with >= 30 years 2. T2D with 6.0 % = 30 mg/g CR] 4. RHI = 2.10 is recognized as normal endothelial function) 5. The patient provided written informed consent to participate in the study
Exclusion criteria
Exclusion criteria: 1. Type 1 diabetes 2. History of clinically apparent atherosclerotic cardiovascular diseases, such as coronary artery disease, stroke, peripheral artery disease, symptomatic carotid artery stenosis 3. Chronic atrial fibrillation 4. History of severe ketosis, diabetic coma, or precoma attack <= 6 months prior to informed consent 5. Severe renal dysfunction (eGFR < 30 mL/min/1.73m2 or undergoing dialysis) 6. Patients received SGLT2 inhibitors within 3 month before informed consent 7. Patients who have changed the type or dose of antidiabetic drugs within 3 months before informed consent 8. Hypersensitivity to ipragliflozin or other SGLT2 inhibitors 9. Symptomatic hypotension, or systolic blood pressure < 90 mm Hg 10. Patients with severe infection or trauma at screening 11. Patients in perioperative period around screening 12. Polysystic kidney disease, lupus nephritis, or ANCA-related vasculitis 13. Pregnant or suspected pregnancy 14. Considered inappropriate for the study by investigators due to other reasons, such as malignancy and suspected poor compliant with clinic visits or prescribed medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change amount in RHI automatically calculated by RH-PAT device from baseline to 24 weeks or at discontinuation of the treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The rate of change in RHI automatically calculated by RH-PAT device from baseline to 24 weeks or at discontinuation of the treatment 2. Prevalence of patients whose RHI substantially increase (LnRHI >15%) from baseline to 24 weeks or at discontinuation of the treatment 3. Prevalence of patients whose RHI recover within normal range (>= 2.10) at 24 weeks 4. Prevalence of patients whose RHI recover within normal range (>= 2.10) or substantially increase (LnRHI >15%) from baseline to 24 weeks or at discontinuation of the treatment 5. Prevalence of patients whose RHI substantially decrease (LnRHI >15%) from baseline to 24 weeks or at discontinuation of the treatment | — |
Contacts
Public ContactAtsushi Tanaka
Saga University Hospital
Outcome results
None listed