Clinical trial NCT02449330: Teneligliptin on the Progressive Left Ventricular Diastolic Dysfunction With Type 2 Diabetes Mellitus Study
Official title: Clinical Study for the Effect of Teneligliptin on the Left Ventricular Diastolic Dysfunction in Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: National Cerebral and Cardiovascular Center, Japan
Sponsor class: OTHER
First posted: 2015-05-20
Enrollment: 936
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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')
timeFrame: Up to 2 years
Secondary outcomes:
measure: Total number of all-cause death
timeFrame: Up to 2 years
measure: Total number of deaths by cardiovascular events
timeFrame: Up to 2 years
measure: Total number of all-cause hospitalization
timeFrame: Up to 2 years
measure: Total number of hospitalization by cardiovascular events
timeFrame: Up to 2 years
measure: Total number of hospitalization by progression of heart failure
timeFrame: Up to 2 years
measure: Total number of incidents for the addition or increase of the agents for heart failure by progression of heart failure
timeFrame: Up to 2 years
measure: 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
timeFrame: Up to 2 years
measure: Change of the deceleration time (DT) by echocardiography
timeFrame: Up to 2 years
measure: Change of the left atrium volume (LAV) by echocardiography
timeFrame: Up to 2 years
measure: Change of the left ventricular end-diastolic diameter (LVDd), left ventricular end-systolic diameter (LVDs) and fractional shortening (%FS) by echocardiography
timeFrame: Up to 2 years
measure: Change of the left ventricular mass index (LVMI) by echocardiography
timeFrame: Up to 2 years
measure: Change of NYHA functional class
timeFrame: Up to 2 years
measure: Change of plasma levels of NT-proBNP
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Suita
country: Japan
facility: National Cerebral and Cardiovascular Center
Study officials:
References: