Type 2 diabetes
Conditions
Interventions
Tofogliflozin treatment group, GroupA: Clinical investigators will initiate tofogliflozin treatment.
Control group, GroupB: Clinical investigators will continue conventional treatment using drugs ot
Sponsors
Osaka University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Only those patients who meet all of the following criteria are included: 1. Japanese T2D patients with poor glycemic control (HbA1c(NGSP) of 6% and above, and below 9.0%), and unable to achieve the blood glucose level stated in the Diabetes Treatment Guideline of 2014-2015, even though they are on drugs except SGLT2i with diet and physical therapy, or on diet and physical therapy only, for at least 12 weeks. Or, those on SGLT2i in the past, but have not used SGLT2i for at least 12 weeks before signing their consent form 2. Patients without any change on their antidiabetic, antithrombotic, or antihypertensive medication, or without taking therapeutic agent for dyslipidemia for at least 12 weeks before signing their consent form 3. Patients aged 30 to 74 at the time of giving their consent 4. Patient who are able to provide their consent form
Exclusion criteria
Exclusion criteria: Those patients who meet one of the following criteria are excluded: 1. Patients with type 1 diabetes, or secondary diabetes 2. Patients in the perioperative period, or with serious infection or injury 3. Patients with a history of myocardial infarction, angina, stroke, or cerebral infarction 4. Patients with severe renal dysfunction or end-stage renal failure (eGFR under 30) 5. Patients with serious liver functional impairment (AST:100 or above) 6. Patients with moderate to severe heart failure (class 3 or worse based on the New York Heart Association (NYHA)Functional Classification) 7. Patients with urinary tract infection, or genital infection 8. Patients who are pregnant, possibly pregnant, nursing, or planning to conceive a child 9. Patients who have a history of hypersensitiveness to the study drug 10. Patients with a malignant tumor or have a history of malignant tumor (exceptions: those are not on medication for malignant tumor, and have no recurrence of the disease so far and without recurrence risks during this study are allowed to participate) 11. Patients who are prohibited to use tofogliflozin 12. Other patients determined ineligible by an investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the IMT value (mean and max IMT) during a 104-week treatment period measured by carotid arterial echography *Particularly focusing on the change of the mean of right and left meanIMT during 104 weeks of the study period | — |
Countries
Japan
Contacts
Public ContactNaoto Katakami
Osaka University Graduate School of Medicine Department of Metabolic Medicine
Outcome results
None listed