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

Sugawara Masahiro0 个研究点目标入组 1,000 人开始时间: 2019年3月15日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•Patients who meet all of the following criteria are included in this study.
•1.Patients with type 2 diabetes mellitus
•2.Male and female aged 20 years or older and younger than 75 years when giving their consent
•3.Patients who did not use antidiabetic medication within 8 weeks before consenting, or patients who used anti-diabetic therapeutic agents** other than SGLT2 inhibitors and DPP-4 inhibitors* and who did not change the usage and the dose of them within 8 weeks before consenting.
•* including once-weekly DPP-4 inhibitors.
•**Patients who use SU can be included in the study, if the patients meet all of the followring criteria.
•i) Patients who regularly receive medical consultation more than once per month within 3 months before consenting.
•ii) Patients whose HbA1c was continuously 7.5% or higher within 3 months before consenting.
•iii) Patients who were considered not to have hypoglycemia within 3 months before consenting.
•iv) Patients who use glimepiride of 2 mg/day or less, or gliclazide of 40 mg/day or less
•4.Patients with HbA1c 6.5% or higher but no more than 10.0% within 12 weeks before consenting.
•5.Patients who can give their consent in a written form

•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 or GLP-1 analogs 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 aged 65 years or older and 74 years or younger with geriatric syndrome (sarcopenia, cognitive dysfuncition, ADL impairment, etc.)
•13.Patients with other conditions that the investigator/researcher thinks inappropriate for the study

发起方

Sugawara Masahiro