diabetic nephropathy in type 2 diabetes mellitus
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1)Diet and exercise therapy only for one month or more, or in addition to diet and exercise therapy, in SGLT2 inhibitors other than oral hypoglycemic agents for one month or more, the glycemic control is insufficient (HbA1c 6.0% or more (NGSP)) 2)Patients who is obtained the consent in writing
Exclusion criteria
Exclusion criteria: 1)Patient with a severe ketotic diabetic coma or precoma. 2)Patient with severe infectious disease, before and after operation, and a serious injury. 3)End-stage renal failure patients with severe renal impairment (eGFR <30mL / min) or during dialysis 4)A pregnant woman or woman who may be pregnant. 5)Patient with a past history of hypersensitivity for Ipragliflozin. 6)Patients who isn't obtained the consent in writing 7)Patient who is considered to be inappropriate by the chief physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)blood glucose lowering effect; fasting blood glucose, HbA1c, 1.5-AG, HOMA-beta, HOMA-R 2)renal function; eGFRcrest, eGFRcys, UACR 3)renal tubular function; u-Na, u-K, u-Cl, u-Mg, u-Ca, u-P, u-Zn, u-UA, u-HCO3, u-pH, FENa, FEK, FECl, FEMg, FECa, FEP, FEZn, FEUA, NAG, u-beta2MG, u-L-FABP, u-Col4 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)oxidant stress; hs-CRP, MDA-LDL, u-isoprostane, u-MCP-1 2)bone metabolic markers; FGF-23, whole PTH 3)lipid profile; LDL-C, HDL-C, TG 4)body fluid volume; NT-proBNP, renin, aldosterone 5)urine volume, urinary pH 6)bood pressure, heart rate, body weight, octopolar bioimpedance 7)RBC, Hb, Erythropoietin | — |
Countries
Japan
Contacts
Saitama Medical Center, Saitama Medical University Department of Nephrology and Hypertention