Clinical Study for the Effect of Teneligliptin on the Progressive Left Ventricular Diastolic Dysfunction in Patients with Type 2 Diabetes Mellitus - TOPLEVEL study

Kitakaze Masafumi0 sites936 target enrollmentMarch 18, 2019

Overview

No summary available.

Registry

who.int

Start Date

March 18, 2019

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Kitakaze Masafumi

•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

•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