Type 2 Diabetes Mellitus
Conditions
Interventions
The arm treated by Teneligliptin in the inhibition test Patients showing E/e'
by echocardiography less than 8 at base line and assigned as Teneligliptin treatment by randomization
The arm treated by anti-diabetic agents except for DPP-4 inhibitors in the inhibition test Pat
by echocardiography less than 8 at base line and assigned as anti-diabetic agents except for DPP-4 inhibitors treatment by randomization
The arm treated by Teneligliptin in the improvement test
by echocardiography more than 8 at base line and assigned as Teneligliptin treatment by randomization
The arm treated by Teneligliptin in the improvement test 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
Sponsors
TOPLEVEL study office
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Asian aged from 20 to 85 years old at baseline 2) 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) 3) Patients with left ventricular ejection fraction more than 40% 4) Patients with written informed consent
Exclusion criteria
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 with a prior history of ileus - 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 - Patients who have already received DPP-4 inhibitors and are not able to change these drugs - 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') for 2 years from baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| - Total number of all-cause death for 2 years from baseline - Total number of deaths by cardiovascular events for 2 years from baseline - Total number of all-cause hospitalization for 2 years from baseline - Total number of hospitalization by cardiovascular events for 2 years from baseline - Total number of hospitalization by progression of heart failure for 2 years from baseline - Total number of incidents for the addition or increase of the agents for heart failure by progression of heart failure for 2 years from baseline - 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 for 2 years from baseline - Change of the deceleration time (DT) by echocardiography for 2 years from baseline - Change of the left atrium volume (LAV) by echocardiography for 2 years from baseline - Change of the left ventricular end-diastolic diameter (LVDd), left ventricular end-systolic diameter (LVDs) and fractional shortening (%FS) by echocardiography for 2 years from baseline - Change of the left ventricular mass index (LVMI) by echocardiography for 2 years from baseline - Change of NYHA functional class for 2 years from baseline - Change of plasma levels of NT-proBNP for 2 years from baseline | — |
Countries
Japan
Contacts
Public ContactMasafumi Kitakaze
National Cerebral and Cardiovascular Center Department of Clinical Medicine and Development
Outcome results
None listed