Diabetes Mellitus, Type 2
Conditions
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.
Interventions
DRUGTeneligliptin
Sponsors
National Cerebral and Cardiovascular Center, Japan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 |
| Total number of all-cause death | 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 |
| Change of the deceleration time (DT) by echocardiography | Up to 2 years |
Countries
Japan
Contacts
Primary ContactMiki Imazu, M.D., Ph.D.
Outcome results
None listed