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JAPANESE
国立保健医療科学院
JRCT ID: jRCTs041200039

Registered date:24/08/2020

Renal Efficacy Study Of LUseogliflozin in patients with Type 2 diabetes mellitus and Impaired renal function

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedType 2 diabetes mellitus
Date of first enrollment19/11/2020
Target sample size200
Countries of recruitment
Study typeInterventional
Intervention(s)Group A: Luseogliflozin add-on group (current treatment + luseogliflozin) Start administration of luseogliflozin within 3 days after the baseline tests. Luseogliflozin is administered to subjects assigned to group A at the initial dose of 2.5 mg before or after breakfast. If glycemic control is insufficient, the dose of luseogliflozin can be increased to 5 mg with careful follow-up. Group B: Current treatment group Subjects assigned to group B continue the current treatment at giving their consent.

Outcome(s)

Primary OutcomeChange in eGFRcreat from baseline to week 104
Secondary OutcomeChange in the following items from baseline to week 4 to 104 1. proportion of subjects who decreased eGFRcreat 30% or more 2. proportion of subjects who decreased eGFRcreat 20% or more 3. proportion of subjects whose eGFRcreat became less than 10 mL/min/1.72m2 4. change in eGFRcreat from week 4 to week 104 5. change in eGFRcys calculated by serum cystatin C from baseline to week 104 6. change in eGFRcys calculated by serum cystatin C from week 4 to week 104 7. proportion of subjects who decreased eGFRcys calculated by serum cystatin C 30% or more 8. proportion of subjects who decreased eGFRcys calculated by serum cystatin C 20% or more 9. change or percent change in urinary albumin/creatinine, L-FABP/creatinine, Ngal/creatinine, and Kim-1/creatinine 10. change in HbA1c 11. change in blood pressure 12. change in lipid biomarkers (TC, TG, LDL-c, HDL-c) 13. change in hepatic biomarkers (AST, ALT, gamma-GTP) 14. change in uric acid 15. change or percent change in serum keton body (total ketone body, 3OHBA, and AcAc) 16. change or percent change in NT-proBNP 17. change in body composition 18. change in handgrip 19. incidence of dialysis

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
Include criteriaPatients who meet all of the following criteria are included in this study: 1. Patients with type 2 diabetes mellitus 2. Patients whose eGFRcreat is 15 ml/min/1.73m2 or higher, and less than 45 ml/min/1.73m2 at the latest visit (within 12 weeks) before giving their consent 3. Patients who did not add or change the dose of new drugs (anti-diabetic agents, antihypertensive agents, therapeutic agents for dyslipidemia, or vitamin D). Patients who changed usage or dose of insulin can be included. 4. Male and female aged 20 years or older at giving their consent 5. Patients who provide their consent in a written form by themselves
Exclude criteriaPatients who fall into any of the following criteria are excluded from participating in the study: 1. Patients who have history of SGLT2 inhibitor use within 3 months before giving their consent. 2. Patients with type 1 diabetes mellitus. 3. Patients with history of severe ketosis, or coma or precoma due to the diabetes mellitus within 1 year before giving their consent. 4. Patients in the perioperative period, or with serious infection or injury 5. Patients who are breastfeeding, pregnant, possibly pregnant, or planning to be pregnant. 6. Patients with history of hypersensitivity against the components of study agent. 7. Patients who use steroids or immunosuppressive agents. Patients who use topical steroids or immunosuppressive agents can be included in this study. 8. Patients who use NSAIDs for pain management purposes. *Patients who use the following NSAIDs can be included in this study. -NSAIDs which have been taken before giving their consent -NSAIDs for antithrombotic purposes -Acetaminophen -Topical agents 9. Patients with severe hepatic dysfunction. (Child-Pugh classification Class C) 10. Patients with history of symptomatic stroke or cerebral infarction. Patients with stable symptoms and no recurrence can be included in this study. 11. Patients with moderate to severe heart failure. (class 3 or worse based on the New York Heart Association (NYHA) Functional Classification) 12. Patients with urinary tract infection, or genital infection. 13. Patients with a malignant tumor or have a history of malignant tumor. Patiens who are not currently treated for malignant tumor, and have no recurrence of the disease so far and without recurrence risks during this study can be included. 14. Patients who need legal representative for giving consent. 15. Patients who are treated by dialysis. 16. Patients with urinary albumin is 5,000mg/gCr or higher. 17. Patients with other conditions that the responsible investigator or sub investigators think inappropriate to participate in the study.

Related Information

Contact

Public contact
Name Munehiro Kitada
Address 811-1,Kimiidera, Wakayama, Wakayama Wakayama Japan 641-8510
Telephone +81-73-447-2300
E-mail kitta@ishinkai-med.com
Affiliation WAKAYAMA MEDICAL UNIVERSITY HOSPITAL
Scientific contact
Name Jun Nakagawa
Address 1-1,Daigaku,Uchinada,Kahoku Ishikawa Japan 920-0293
Telephone +81-76-286-3511
E-mail atch-n@kanazawa-med.ac.jp
Affiliation Kanazawa Medical University Hospital