Type 2 diabetes with diabetic nephropathy
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with type 2 diabetes 2. HbA1c higher than 6.5% and lower than 11.0% 3. BMI higher than 22 and lower than 45 kg/m2 4. Patients who have been treated diet/exercise therapy alone, or patients treated with oral anti-diabetic drugs without SGLT2 inhibitor and/or insulin therapy at baseline. 5. Patients who are able to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients who have history or current serious diabetic complication. 2. Patients that insulin dependence is suspected. 3. Patients who have history or current cardiac failure (New York Heart Association Class III or IV), myocardial infarction or cerebrovascular disorder. 4. Patients whose eGFR lower than 45 mL/min/1.73m2, serum creatinine higher than 1.5 mg/dL. 5. Patients who have hepatic dysfunction.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in HbA1c | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes from baseline in urinary albumin-to-creatinine ratio (UACR), eGFR, blood pressure, body weight, fasting plasma glucose, fasting serum lipids, AST, ALT, and uric acid at week 104. | — |
Countries
Japan
Contacts
Ogawa Red Cross Hospital Department of Internal Medicine