Type 2 diabetes mellitus Type 2 diabetes mellitus
Conditions
Interventions
arm A(Tofogliflozin)
Tofogliflozin 20 mg/day is administered orally after breakfast for 12 weeks.
After that, Empagliflozin 10 mg/day is administered orally after breakfast for 12 weeks.
armB(Empaglif
Sponsors
Yamada Yoshihiko
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NT-proBNP(comparison of drugs). | — |
Secondary
| Measure | Time frame |
|---|---|
| Value of following indexes(comparison of drugs).Change or change percentage from baseline to the 12th week(comparison of drugs, before and after medication). HbA1c, blood glucose,insulin, C peptide,body weight, BMI, blood pressure,eGFR, serum creatinine, urinary albumin, urinary L-FABP,NT-proBNP, high sensitive troponin T,ALT, AST, gamma-GTP TC, LDL-C, TG, HDL-C,ketone body(3-hydroxy butyric acid, acetoacetic acid, total ketone body), free fatty acid,uric acid, lactic acid, pyruvic acid, LDH, lactic acid/ pyruvic acid,hsCRP,adverse event | — |
Contacts
Public ContactYoshihiko Yamada
International University of Health and Welfare Atami Hospital
Outcome results
None listed