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

• Status: Recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cerebral and Cardiovascular Center

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