Type 2 diabetes with/without diabetic nephropathy
Conditions
Interventions
Ipragliflozin 50 mg per day for 24 weeks
Sponsors
Ogawa Red Cross Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Type 2 diabetic patients 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, bodyweight, fasting plasma glucose, fasting serum lipids, abdominal adipose tissue, AST, ALT, and uric acid at week 24. | — |
Countries
Japan
Contacts
Public ContactDaisuke Ito
Ogawa Red Cross Hospital Division of Internal Medicine
Outcome results
None listed