Type 2 diabetes mellitus Type 2 diabetes mellitus, SGLT2 inhibitor, Luseogliflozin
Conditions
Interventions
Adding Luseogliflozin (Lusefi 2.5 mg) on previous medications and assessing at 0, 4 and 12 weeks after administration
Sponsors
Kario Kazuomi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Type 2 diabetes mellitus (no medication or using a diabetic medicine) (2) HbA1c 6.5-9.0% within 4 weeks before registration (3) Patients who are planned or considered to take or add a diabetes medication by the physicians (4) Possible to take Luseogliflozin (5) 20-74 years old (6) Written informed consent
Exclusion criteria
Exclusion criteria: (1) T1 diabetes mellitus (2)Using SGLT2 inhibitors (3) Using insulin (4) Using GLP-1 receptor agonist (5) Patients who have been changed medications for hypertension or hyperglycemia for recent 12 weeks (6)History of serious sensitivity of SGLT2 inhibitors (7) History of cerebral infraction (8)Severe renal dysfunction (eGFR<30ml/min/1.73m2) or under going dialysis (9) Severe liver dysfunction (10)Pituitary dysfunction or adrenal insufficiency (11)Pregnant, possibly pregnant or breast feeding (12) Participants of other clinical studies except observational studies (13) The physicians consider that the patients are inappropriate for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Variations of CAVI from the beginning of treatment to week 4 and week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Variations of the following items from the beginning of treatment to week 4 and week 12. (1) Ankle Brachial Pressure Index; ABI, Pulse Wave Velocity; PWV (2) Electrocardiogram examination (3) Blood pressure: average of SBP, DBP, heart rate and BP variations (home BP and office BP) (4) Metabolic factors: HbA1c, body weight, BMI, lipid and uric acid | — |
Contacts
Public ContactSatoshi Hoshide
Jichi Medical University Hospital
Outcome results
None listed