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

  • STATUS
    Recruiting
  • End date
    Jun 22, 2023
  • participants needed
    936
  • sponsor
    National Cerebral and Cardiovascular Center
Updated on 22 January 2021
antidiabetic agents

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.

Details
Condition NIDDM, Diabetes Mellitus, Type 2, Diabetes Mellitus Type 2, type 2 diabetes mellitus, type 2 diabetes, type ii diabetes, noninsulin-dependent diabetes mellitus, diabetes type 2
Treatment Teneligliptin
Clinical Study IdentifierNCT02449330
SponsorNational Cerebral and Cardiovascular Center
Last Modified on22 January 2021

Eligibility

Yes No Not Sure

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
Patients necessary to start the treatment using anti-diabetic agent(s) or to change the anti-diabetic agent(s)
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
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