The inhibitory effects of the SGLT2 inhibitor for progression of diabetic nephropathy, in the patients with type 2 diabetes in Japan.

Not Applicable

• Conditions: diabetic nephropathy in type 2 diabetes mellitus

• Registration Number: JPRN-UMIN000016754
• Lead Sponsor: Saitama Medical Center, Saitama Medical University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-04-01
• Study Completion: 2020-12-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up continuing
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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