Clinical Study for the Effect of Teneligliptin on the Left Ventricular Diastolic Dysfunction in Patients with Type 2 Diabetes Mellitus

INTERVENTION: The arm treated by Teneligliptin in the inhibition test Patients showing E/e' by echocardiography less than 8 at base line and assigned as Teneligliptin treatment by randomization The arm treated by anti‐diabetic agents except for DPP‐4 inhibitors in the inhibition test Patients showing E/e' by echocardiography less than 8 at base line and assigned as anti‐diabetic agents except for DPP‐4 inhibitors treatment by randomization The arm treated by Teneligliptin in the improvement test Patients showing E/e' by echocardiography more than 8 at base line and assigned as Teneligliptin treatment by randomization The arm treated by Teneligliptin in the improvement test Patients showing E/e' by echocardiography more than 8 at base line and assigned as anti‐diabetic agents except for DPP‐4 inhibitors treatment by randomization CONDITION: Type 2 Diabetes Mellitus PRIMARY OUTCOME: Change of the ratio of peak velocity of early transmitral diastolic filling by echocardiography (E) to early diastolic mitral annular velocity by tissue Doppler echocardiography (E/e') for 2 years from baseline SECONDARY OUTCOME: ‐ Total number of all‐cause death for 2 years from baseline; ‐ Total number of deaths by cardiovascular events for 2 years from baseline; ‐ Total number of all‐cause hospitalization for 2 years from baseline; ‐ Total number of hospitalization by cardiovascular events for 2 years from baseline; ‐ Total number of hospitalization by progression of heart failure for 2 years from baseline; ‐ Total number of incidents for the addition or increase of the agents for heart failure by progression of heart failure for 2 years from baseline; ‐ Change of the ratio of peak velocity of early transmitral diastolic filling (E) to late diastolic filling due to atrial contraction (E/A) by echocardiography for 2 years from baseline; ‐ Change of the deceleration time (DT) by echocardiography for 2 years from baseline; ‐ Change of the left atrium volume (LAV) by echocardiography for 2 years from baseline; ‐ Change of the left ventricular end‐diastolic diameter (LVDd), left ventricular end‐systolic diameter (LVDs) and fractional shortening (%FS) by echocardiography for 2 years from baseline; ‐ Change of the left ventricular mass index (LVMI) by echocardiography for 2 years from baseline; ‐ Change of NYHA functional class for 2 years from baseline; ‐ Change of plasma levels of NT‐proBNP for 2 years from baseline INCLUSION CRITERIA: 1) Japanese aged from 20 to 85 years old at baseline 2) Patients with type 2 diabetes mellitus and including either a) or b) criteria a)Patients necessary to start the treatment using anti‐diabetic agent(s) or to change the anti‐diabetic agent(s) b)Patients possible to change the anti‐diabetic agent(s) 3) Patients with left ventricular ejection fraction more than 40% 4) Patients with written informed consent