Tofogliflozin And Empagliflozin Cross-over TrIal(TACTICS)

JRCT ID: jRCTs031190021

Registered date:10/05/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Type 2 diabetes mellitus
• Date of first enrollment: 29/08/2019
• Target sample size: 60
• Study type: Interventional

Intervention(s)

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(Empagliflozin)
Empagliflozin 10 mg/day is administered orally after breakfast for 12 weeks.
After that, Tofogliflozin 20 mg/day is administered orally after breakfast for 12 weeks.

Outcome(s)

• Primary Outcome: NT-proBNP(comparison of drugs).

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 75age old
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Yamada Yoshihiko
• Source(s) of Monetary Support: Kowa Co. Ltd.