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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Teneligliptin in the inhibition test | Experimental | Patients showing E/e' by echocardiography less than 8 at base line and assigned as Teneligliptin treatment by randomization |
|
| Other agents in the inhibition test | No Intervention | 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 | |
| Teneligliptin in the improvement test | Experimental | Patients showing E/e' by echocardiography more than 8 at base line and assigned as Teneligliptin treatment by randomization |
|
| Other agents in the improvement test | No Intervention | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teneligliptin | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion 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).
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Miki Imazu, M.D., Ph.D. | Contact | 81-6-6833-5012 | 2225 | mimadu@ncvc.go.jp |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cerebral and Cardiovascular Center | Recruiting | Suita | 565-8565 | Japan |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C579035 | 3-(4-(4-(3-methyl-1-phenyl-1H-pyrazol-5-yl)piperazin-1-yl)pyrrolidin-2-ylcarbonyl)thiazolidine |
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| 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 |
| D004700 | Endocrine System Diseases |