Type2 Diabetes
Conditions
Interventions
Patients receive the NHI-covered standard treatment for 6 months, add-on Luseogliflozin 2.5mg/day to standard treatment additional 6 months.
Sponsors
Matoba Satoaki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Diagnosis of type 2 diabetes mellitus with NYHA Class 2 or 3 2) Glycosylated haemoglobin (HbA1c) of =400pg/ml 4) Age >= 65 years and <90 years 5) Prior to informed consent
Exclusion criteria
Exclusion criteria: 1) Contraindications to Luseogliflozin 2) SGLT2 inhibitor therapy within 28 days prior to informed consent 3) eGFR <30 ml/min /1.73m2 or Dialysis 4) Life expectancy <6 months 5) Severe complication (significant liver disease (Child-Pugh classification B or C), active bleeding(intracranial hemorrhage, gastrointestinal bleeding, etc.), clinic blood pressure with a SBP of more than 180 mm Hg or a DBP of more than 110 mm Hg) 6) Patient with implantable defibrillator or pacemaker
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Levels of changes in NT-proBNP before and after add-on Luseogliflozin therapy period | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes of NT-proBNP at 6 months from baseline. Changes of several parameters at 6 months from baseline. Changes of several parameters at 6 months after Luseogliflozin administration. | — |
Contacts
Public ContactNoriyuki Wakana
University Hospital, Kyoto Prefectural University of Medicine
Outcome results
None listed