Type2 DM
Conditions
Interventions
Treatment with empagliflozin 10mg (usual dose in Japan) once a daily for 12 weeks.
Treatment with sitagliptin 50mg (usual dose in Japan) once a daily for 12 weeks.
Sponsors
Kyushu University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Age >20 years and <85 years males and females 2)Inadequately controlled type 2 diabetic patients HbA1c >= 6.0% and HbA1c < 10% 3)Type 2 diabetic patients with LV ejection fraction > 50% and a symptom of heart failure (NYHA II or III) 4)BNP >= 35pg/dL 5)Patients from whom a written informed consent are obtained
Exclusion criteria
Exclusion criteria: 1)Other than T2DM such as T1DM and secondary DM. 2)Patients with severe infection, perioperative patients, patients with severe trauma. 3)Patients receiving SGLT2 inhibitor and/or incretin-related drugs within 2 months before ingestion of study drug. 4)Patients with idiopathic cardiomyopathy, Fabry disease, Amyloidosis cardiomyopathy. 5)Patients with renal insufficiency (eGFR< 45 ml/min/1.73m2). 6)Patients with severe respiratory disease, severe musculoskeletal conditions and unable to exercise challenge test for any other diseases, and severe anemia. 7)Any uncontrolled endocrine disorder except type 2 diabetes. 8)Acute coronary syndrome, stroke, or transient ischemic attack within 3 months of IC. 9)Patient who is scheduled to undergo surgery within 3 months before IC or plan to operate within 3 months after IC. 10)Patients who have a heart pacemaker, who have an aneurysm clip in their brain more than 20 years ago, or have a body implantation device (Implanted cardioverter-defibrillator , Cochlear, otologic, or other ear implant, or Neurostimulation system). 11)Patients with severe claustrophobia. 12)Patients who are pregnant or breast-feeding. 13)Patients lower than BMI 20. 14)Patients in hyperglycemic crisis or accompanied with marked symptom of hyperglycemia and /or DKA. 15)Patients considered inappropriate to participate in the study by the principal and/or sub- investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Aim of this study is to investigate whether empagliflozin could improve heart failure (HF) of T2DM patients with HFpEF (heart failure with preserved ejection fraction). Severity and improvement of HF is evaluated by oxygen uptake efficiency (Peak VO2) obtained during the submaximal portion of cardiopulmonary exercise testing (CPET), which is one of the most reliable and accurate parameter of HF severity. | — |
Countries
Japan
Contacts
Public ContactRikako Sagara
Kyushu University Hospital Endocrinology and Metabolism
Outcome results
None listed