Type2 Diabetes
Conditions
Interventions
The standard treatment (no use of SGLT2 inhibitors nor insulin injection)will be continued and observed for the predefined items for six months at maximum.
2.5mg of Luseogliflozin will be given dail
Sponsors
Cardiovascular internal medicine Medical Corporataion Juryo Kumamoto Kinoh Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Type 2 diabetes patients who fulfill the following conditions; 1)Signed informed consent to join the study. 2)HbA1c level on the day of the consent signature is no less than 6.0% and no more than 12.0%. 3)Up to the day of the signature, have a history of heart failure, and ecocardiography taken within one year shows EF of no more than 55% or E/e' of no less than 15, with or without atrial fibrillation (AF). 4)WIthin 8 weeks up to the day of the signature, BNP level is no less than 40pg/mL or NT-proBNP is no less than 150pg/mL. 5)Within 8 weeks up to the day of the signature, the severity of heart failure is judged II to III according to the categorization by New York Heart Association (NYHA). 6)Cardiac catheterization is required to evaluate cardiac function and coronary artery condition.
Exclusion criteria
Exclusion criteria: Any person who 1)Has type I diabetes. 2)Requires insulin for blood glucose control (including the conditions such as severe ketosis, diabetic coma or precoma, severe infectious disease, perioperative period, or severe trauma). 3)Had severe renal dysfunction (estimated glomerular filtration rate (eGFR) is less than 45mL/min/1.73m2 or dialysis is required). 4)Has severe hepatic dysfunciton. 5)Has a history of the following disorders within 12 weeks up to the day of the signature;acute coronary syndromes, cerebrovascular disorder, myocarditis, pericarditis constrictiva, or severe valvular disorder. 6)Has heart failure of severity IV according to the categorization by New York Heart Association (NYHA). 7)Body mass index (BMI) is less than 18.5kg/m2 or at malnutrition or starvation state. 8)Has a history of intolerance to the target drug. 9)Is pregnant, breast-feeding, or likely pregnant. 10)Is diagnosed of malignant tumor or so suspected. 11)Is a the age of 85 or older. 12)Is judged inappropriate for the study by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the quantity and rate of keton absorbed by cardiac muscles in the second week of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Improvement in cardiac function in the second week and 6th month of treatment:brain natriuretic peptide (BNP), left ventricular diastolic performance (E/e'), and ejection fraction (EF). 2)Change in Hemoglobin A1c(HbA1c) and blood glucose level from the base line (zero week of treatment). 3)Change in BNP (and N-terminal pro-brain natriuretic peptide(NT-proBNP)from the base line (zero week of treatment). 4)Echocardiographic evaluation:E/e',LV mass index, EF, LA volume index. 5)Change in glycometabolism and fatty acid metabolism ove the two weeks of treatment. 6)Change in keton concentration over the two weeks of treatment and its relation to ALDH2 gene polymorphism. 7)Change in vascular endothelial function over the two weeks of treatment. 8)Hemodynamic status by right heart catheter over the two weeks of treatment. 9)Change in troponin T level over the two weeks of treatment. 10)Change in holter electrocardiogram over the two weeks of treatment. 11)Change in renal function over the six months of treatment. | — |
Countries
Japan
Contacts
Public ContactYuji Mizuno
Medical Corporataion Juryo Kumamoto Kinoh Hospital Cardiovascular internal medicine
Outcome results
None listed