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

TOPLEVEL study office0 sites936 target enrollmentAugust 1, 2014

ConditionsType 2 Diabetes Mellitus

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Type 2 Diabetes Mellitus
Sponsor: TOPLEVEL study office
Enrollment: 936
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 1, 2014

End Date

June 30, 2022

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

TOPLEVEL study office

Eligibility Criteria

Inclusion Criteria

Not provided

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 with a prior history of ileus \- 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 \- Patients who have already received DPP\-4 inhibitors and are not able to change these drugs \- 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