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The Japanese Study for Efficacy of Luseogliflozin on composite Endpoint, Compared to DPP-4 inhibitors, in Type 2 diabetes mellitus patients (J-SELECT study)

Not Applicable
Conditions
Type 2 Diabetes Mellitus
Registration Number
JPRN-UMIN000030128
Lead Sponsor
Japan Physicians Association
Brief Summary

npublished because the results of this study is now submitted to an academic journal

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
623
Inclusion Criteria

Not provided

Exclusion Criteria

Patients who fall into any of the following criteria are excluded from participating in the study. 1. Type 1 diabetes mellitus or secondary diabetes 2. Patients who used insulin, GLP-1 analogs, or SU within 8 weeks before consenting 3. Patients who had myocardial infarction, cerebral infarction, or stroke within 12 weeks before giving their consent 4. Patients with severe liver disease (Patients with AST or ALT value five times or more of the upper limit of the stand value in each research institution) 5. Patients with serious renal disease (eGFR less than 30 mL/min/1.73m2) 6. Patients with unstable hypertension and dyslipidemia 7. Dehydrated patients (patients complain to have a symptom of dehydration) 8. Patients with urinary tract infection or genital infection 9. Patients who are breastfeeding, pregnant, possibly pregnant, or planning to be pregnant 10. Contraindication: patients with hypersensitivity to any medical component of each study drug 11. Patients who need legal representative for giving consent 12.Patients with other conditions that the investigator/researcher thinks inappropriate for the study

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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