| Trial ID: | L2371 |
| Source ID: | NCT02449330
|
| Associated Drug: |
Teneligliptin
|
| Title: |
Teneligliptin on the Progressive Left Ventricular Diastolic Dysfunction With Type 2 Diabetes Mellitus Study
|
| Acronym: |
TOPLEVEL
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Teneligliptin
|
| Outcome Measures: |
Primary: 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'), Up to 2 years | Secondary: Total number of all-cause death, Up to 2 years|Total number of deaths by cardiovascular events, Up to 2 years|Total number of all-cause hospitalization, Up to 2 years|Total number of hospitalization by cardiovascular events, Up to 2 years|Total number of hospitalization by progression of heart failure, Up to 2 years|Total number of incidents for the addition or increase of the agents for heart failure by progression of heart failure, 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, Up to 2 years|Change of the deceleration time (DT) by echocardiography, Up to 2 years|Change of the left atrium volume (LAV) by echocardiography, Up to 2 years|Change of the left ventricular end-diastolic diameter (LVDd), left ventricular end-systolic diameter (LVDs) and fractional shortening (%FS) by echocardiography, Up to 2 years|Change of the left ventricular mass index (LVMI) by echocardiography, Up to 2 years|Change of NYHA functional class, Up to 2 years|Change of plasma levels of NT-proBNP, Up to 2 years
|
| Sponsor/Collaborators: |
Sponsor: National Cerebral and Cardiovascular Center, Japan
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
936
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2015-06
|
| Completion Date: |
2023-06
|
| Results First Posted: |
|
| Last Update Posted: |
2018-08-22
|
| Locations: |
National Cerebral and Cardiovascular Center, Suita, 565-8565, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT02449330
|
