JPRN-jRCTs031190021Completed未知
Tofogliflozin And Empagliflozin Cross-over TrIal to Compare the effects on NT-proBNP in patients with type 2 diabeteS (TACTICS)
Yamada Yoshihiko0 sites56 target enrollmentStarted: May 10, 2019Last updated:
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 56
Study Overview
Brief Summary
In the blood NT-proBNP value and the main laboratory parameters, no significant difference was found the effect between the drugs. The value of eGFR during the tofogliflozin administration period was significantly higher than the value during the empagliflozin administration period. For some parameters, a significant difference was found between the treatment groups in the comparison of the rate of change before and after administration of the study drug.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 20age old to < 75age old (—)
- Sex
- All
Inclusion Criteria
- •1.Type 2 diabetes mellitus.
- •2.HbA1c is 6.5-9.9%. (measured within 90 days before consent)
- •3.Men or woman, aged 20-74years.
- •4.Patients who provide written consent to participate in the trial of their own free will.
Exclusion Criteria
- •1.Type 1 diabetes mellitus.
- •2.Patients using insulin.
- •3.Patients using SGLT2 inhibitors within 4 weeks before consent.
- •4.BMI is less than 18.5 kg/m2 within 90 days before consent.
- •5.History of cerebral infarction.
- •6.Serious hepatic dysfunction or hepatic biomarker is more than 2.5 times upper limit of normal(measured within 90 days before consent).
- •7.Serious renal dysfunction or eGFR is less than 30 mL /min/1.73 m2(measured within 90 days before consent).
- •8.Heart failure (NYHA III or more).
- •9.Severe ketosis, diabetic coma or precoma.
- •10.Sever infection, within one week before or after the surgery, sever injury.
- •11.History of hypersensitivity to any of the ingredients of the study drug.
- •12.Pregnant women, women suspected of being pregnant.
- •13.Patients who are ineligible in the opinion of the investigator.
Investigators
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