type 2 diabetes with nonalcoholic fatty liver disease at risk for heart failure
Conditions
Interventions
Tofogliflozin group: 20 mg tofogliflozin will be orally administered until 24 weeks
Standard-therapy group: continuous treatment with diabetes other than SGLT2 inhibitors until 24 weeks
Sponsors
Noguchi Michio
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Patients aged >= 20 and 9 5 Patients with HbA1c 10% or less 6 Patients with written informed consent
Exclusion criteria
Exclusion criteria: 1 eGFR < 45 ml/min/1.73 m2 at screening 2 Patients with chronic heart failure NYHA class II-IV and reduced ejection fraction (LVEF <= 40 %) 3 Patients with suspected severe liver fibrosis 4 Patients with acute myocardial infarction, ampulla cardiomyopathy and acute myocarditis in the prior 24 weeks 5 Patients who have underwent coronary revascularization by PCI or bypass surgery in the prior 8 weeks 6 Patients in whom coronary revascularization is being contemplated within 24 weeks 7 Diagnosed cardiac amyloidosis 8 Diagnosed persistent atrial fibrillation 9 Patients who have underwent valve replacement surgery, pacemaker implantation including cardiac resynchronization therapy or ICD implantation 10 Conditions preventing safe contrast-enhanced MRI imaging 11 Patients with contraindication to tofogliflozin 12 Patients treated with SGLT2 inhibitors within 12 weeks 13 Diagnosed idiopathic pulmonary fibrosis 14 Diagnosed malignant tumors 15 Female who are pregnant, breast-feeding, or may be pregnant 16 Subjects who have participated or plan to participate in another clinical research 17 Patients who were judged by the investigator to be inappropriate for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in indexed extracellular volume (iECV) from baseline to 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Changes in LVMi (MRI) from baseline to 24 weeks 2 Changes in Indexed cell volume (MRI) from baseline to 24 weeks 3 Changes in ECVf (MRI) from baseline to 24 weeks 4 Changes in Native T1 value (MRI) from baseline to 24 weeks 5 Changes in LV end-diastolic volume and end-sysytolic volume (MRI) from baseline to 24 weeks 6 Changes in RV end-diastolic volume and end-sysytolic volume (MRI) from baseline to 24 weeks 7 Changes in LVEF (MRI) from baseline to 24 weeks 8 Changes in RVEF (MRI) from baseline to 24 weeks 9 Changes in LVM/LVEDV (MRI) from baseline to 24 weeks 10 Changes in E/e' (echocardiography) from baseline to 24 weeks 11 Changes in AST, ALT, GGT from baseline to 12, 24 weeks 12 Changes in FIB4 index from baseline to 12, 24 weeks 13 Changes in HbA1c from baseline to 12, 24 weeks 14 Changes in body weight from baseline to 12, 24 weeks 15 Changes in blood pressure (systolic diastolic and mean) from baseline to 12, 24 weeks | — |
Contacts
Public ContactMichio Noguchi
National Cerebral and Cardiovascular Center
Outcome results
None listed