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

Not Applicable

Recruiting

• Conditions: Type 2 diabetes mellitus

• Registration Number: JPRN-jRCTs041200039
• Lead Sponsor: akagawa Jun

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-08-24
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Patients 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

Exclusion Criteria

Patients 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified