Multicenter explorative study of the beneficial effect of Luseogliflozin on cardiovascular function in Japanese T2DM patients (LUSCAR Study)
- Conditions
- Type 2 diabetes mellitusType 2 diabetes mellitus, SGLT2 inhibitor, Luseogliflozin
- Registration Number
- JPRN-jRCTs031180434
- Lead Sponsor
- Kario Kazuomi
- Brief Summary
This study investigated the effects of the SGLT2 inhibitor, luseogliflozin, on arterial properties and home blood pressure (BP) in patients with T2DM. This was a multicenter, single-arm study. Luseogliflozin 2.5 mg/day was given for 12 weeks. In conclusion, there was no change in arterial stiffness based on CAVI in the study period; however, changes in BP and metabolic parameters were consistent with the documented beneficial effects of SGLT2 inhibitors in T2DM.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 48
(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
(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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method