TOPLEVEL study

JRCT ID: jRCTs051180136

Registered date:18/03/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Type 2 Diabetes Mellitus
• Date of first enrollment: 24/06/2015
• Target sample size: 936
• Study type: Interventional

Intervention(s)

1)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
2)The arm treated by anti-diabetic agents except for DPP-4 inhibitors in the inhibition test
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
3)The arm treated by Teneligliptin in the improvement test
Patients showing E/e' by echocardiography more than 8 at base line and assigned as Teneligliptin treatment by randomization
4)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

Outcome(s)

• Primary Outcome: 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 Outcome

(1) Total number of all-cause death for 2 years from baseline
(2) Total number of deaths by cardiovascular events for 2 years from baseline
(3) Total number of all-cause hospitalization for 2 years from baseline
(4) Total number of hospitalization by cardiovascular events for 2 years from baseline
(5) Total number of hospitalization by progression of heart failure for 2 years from baseline
(6) 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
(7) 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
(8) Change of the deceleration time (DT) by echocardiography for 2 years from baseline
(9) Change of the left atrium volume (LAV) by echocardiography for 2 years from baseline
(10) 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
(11) Change of the left ventricular mass index (LVMI) by echocardiography for 2 years from baseline
(12) Change of NYHA functional class for 2 years from baseline
(13) Change of plasma levels of NT-proBNP for 2 years from baseline
(14) Change of early diastolic mitral annular velocity by tissue doppler echocardiography (e') for 2years
from baseline
(15) Change of tricuspid regurgitation velocity by echocardiography for 2years from baseline
(16) Incidence of new-onset atrial fibrillation, atrial flutter, and atrial fibrillation plus atrial flutter in 2years

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 85age old
• Gender: Both

Include 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

Exclude criteria

1) Patients with type 1 diabetes mellitus
2) 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
3) Patients with diabetes mellitus caused by evident genetic factors
4) Patients with diabetes mellitus caused by secondary factors as endocrine disease or liver disease
5) Patients with diabetic ketoacidosis or hyperosmolar hyperglycemic syndrome
6) Patients with any severe infectious diseases or planed any surgical treatments or suffered any severe traumas
7) Patients with severe liver dysfunction
8) Patients with hypophyseoprivic or adrenal insufficiency
9) Patients under malnutrition or starved state or irregular caloric intake or calorie insufficiency or hyposthenia
10) Patients judged to be unsuitable for the study as they are planning to exercise intensively
11) Patients judged to be unsuitable for the study as they may drink excessively or abuse drugs
12) Patients with a prior history of ileus
13)Patients showing QT prolongation in the electrocardiogram
14) Patients with any past histories of heart failure showing NYHA classification grade more than 3 at baseline
15) Patients with any past histories of acute coronary syndrome or coronary intervention or cardiac surgery developed within 6 months
16) Patients with any surgical past histories of mitral valve replacement or mitral valve repair or severe calcification of mitral valve
17) Patients already treated with Teneligliptin
18) Patients who have already received DPP-4 inhibitors and are not able to change these drug
19) Women with breast-feeding
20) Pregnant women or patients who have possibilities of pregnancy
21) Patients expected to live less than 3 years
22)Patients with any past histories of drug hypersensitivity against Teneligliptin
23) Patients already involved in any other interventional clinical trials or planned to be involved
24) Patients judged to be inappropriate for the study by the doctors in charge

Related Information

• Primary Sponsor: Kitakaze Masafumi
• Source(s) of Monetary Support: Mitsubishi Tanabe Pharma Corporation,Mitsubishi Tanabe Pharma Corporation
• Secondary ID(s): UMIN000014589