Teneligliptin on the Progressive Left Ventricular Diastolic Dysfunction With Type 2 Diabetes Mellitus Study

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Teneligliptin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Asians aged from 20 to 85 years old at baseline 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). Patients with left ventricular ejection fraction more than 40% Patients with written informed consent Exclusion Criteria: Patients with type 1 diabetes mellitus Patients with slowly progressive type 1 diabetes mellitus positive for pancreatic islets related autoimmune antibody as GAD antibody or IA-2 antibody or ICA antibody Patients with diabetes mellitus caused by evident genetic factors Patients with diabetes mellitus caused by secondary factors as endocrine disease or liver disease Patients with diabetic ketoacidosis or hyperosmolar hyperglycemic syndrome Patients with any severe infectious diseases or planed any surgical treatments or suffered any severe traumas Patients with severe liver dysfunction Patients with hypophyseoprivic or adrenal insufficiency Patients under malnutrition or starved state or irregular caloric intake or calorie insufficiency or hyposthenia Patients judged to be unsuitable for the study as they are planning to exercise intensively Patients judged to be unsuitable for the study as they may drink excessively or abuse drugs Patients showing QT prolongation in the electrocardiogram Patients with any past histories of heart failure showing NYHA classification grade more than 3 at baseline Patients with any past histories of acute coronary syndrome or coronary intervention or cardiac surgery developed within 6 months Patients with any surgical past histories of mitral valve replacement or mitral valve repair or severe calcification of mitral valve Patients already treated with Teneligliptin Women with breast-feeding Pregnant women or patients who have possibilities of pregnancy Patients expected to live less than 3 years Patients with any past histories of drug hypersensitivity against Teneligliptin Patients already involved in any other interventional clinical trials or planned to be involved Patients judged to be inappropriate for the study by the doctors in charge

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Teneligliptin in the inhibition test<br>Patients showing E/e' by echocardiography less than 8 at base line and assigned as Teneligliptin treatment by randomization | Drug: Teneligliptin<br> <br> |
| No Intervention: Other agents in the inhibition test<br>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 | |
| Experimental: Teneligliptin in the improvement test<br>Patients showing E/e' by echocardiography more than 8 at base line and assigned as Teneligliptin treatment by randomization | Drug: Teneligliptin<br> <br> |
| No Intervention: Other agents in the improvement test<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 |