This is the clinical trial designed to assess the cardiac diastolic function of long term treatment with teneligliptin compared to that without teneligliptin in patients with type 2 diabetes mellitus by two arms; one includes patients showing E/e' by echocardiography less than 8, the other includes patients showing E/e' by echocardiography more than 8.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
936
National Cerebral and Cardiovascular Center
Suita, Japan
RECRUITINGChange 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')
Time frame: Up to 2 years
Total number of all-cause death
Time frame: Up to 2 years
Total number of deaths by cardiovascular events
Time frame: Up to 2 years
Total number of all-cause hospitalization
Time frame: Up to 2 years
Total number of hospitalization by cardiovascular events
Time frame: Up to 2 years
Total number of hospitalization by progression of heart failure
Time frame: Up to 2 years
Total number of incidents for the addition or increase of the agents for heart failure by progression of heart failure
Time frame: Up to 2 years
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
Time frame: Up to 2 years
Change of the deceleration time (DT) by echocardiography
Time frame: Up to 2 years
Change of the left atrium volume (LAV) by echocardiography
Time frame: Up to 2 years
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Change of the left ventricular end-diastolic diameter (LVDd), left ventricular end-systolic diameter (LVDs) and fractional shortening (%FS) by echocardiography
Time frame: Up to 2 years
Change of the left ventricular mass index (LVMI) by echocardiography
Time frame: Up to 2 years
Change of NYHA functional class
Time frame: Up to 2 years
Change of plasma levels of NT-proBNP
Time frame: Up to 2 years