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

Diabetes Mellitus, Type 2 Clinical Trial

— TOPLEVEL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02449330
• Other study ID #: M26-43
• Status: Recruiting
• Phase: Phase 4
• Start date: June 2015
• Est. completion date: June 2023

Study information

• Verified date: August 2018
• Source: National Cerebral and Cardiovascular Center
• Contact: Miki Imazu, M.D., Ph.D.
• Phone: 81-6-6833-5012
• Email: mimadu[@]ncvc.go.jp
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 936
• Est. completion date: June 2023
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Ventricular Dysfunction, Left

Intervention

Drug:
• Teneligliptin

Locations

Country	Name	City	State
Japan	National Cerebral and Cardiovascular Center	Suita

Sponsors (1)

Lead Sponsor	Collaborator
National Cerebral and Cardiovascular Center

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Total number of all-cause death		Up to 2 years
Secondary	Total number of deaths by cardiovascular events		Up to 2 years
Secondary	Total number of all-cause hospitalization		Up to 2 years
Secondary	Total number of hospitalization by cardiovascular events		Up to 2 years
Secondary	Total number of hospitalization by progression of heart failure		Up to 2 years
Secondary	Total number of incidents for the addition or increase of the agents for heart failure by progression of heart failure		Up to 2 years
Secondary	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
Secondary	Change of the deceleration time (DT) by echocardiography		Up to 2 years
Secondary	Change of the left atrium volume (LAV) by echocardiography		Up to 2 years
Secondary	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
Secondary	Change of the left ventricular mass index (LVMI) by echocardiography		Up to 2 years
Secondary	Change of NYHA functional class		Up to 2 years
Secondary	Change of plasma levels of NT-proBNP		Up to 2 years