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

National Cerebral and Cardiovascular Center, Japan

Status and phase: Unknown; Phase 4

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Teneligliptin

Study type: Interventional

Funder types: Other

Identifiers

NCT02449330

M26-43

Details and patient eligibility

About

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.

Enrollment: 936 estimated patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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936 participants in 4 patient groups

Teneligliptin in the inhibition test

Experimental group

Description:

Patients showing E/e' by echocardiography less than 8 at base line and assigned as Teneligliptin treatment by randomization

Treatment:

Drug: Teneligliptin

Other agents in the inhibition test

No Intervention group

Description:

Patients showing E/e' by echocardiography less than 8 at base line and assigned as anti-diabetic agents except for DPP-4 inhibitors treatment by randomization

Teneligliptin in the improvement test

Experimental group

Description:

Patients showing E/e' by echocardiography more than 8 at base line and assigned as Teneligliptin treatment by randomization

Treatment:

Drug: Teneligliptin

Other agents in the improvement test

No Intervention group

Description:

Patients showing E/e' by echocardiography more than 8 at base line and assigned as anti-diabetic agents except for DPP-4 inhibitors treatment by randomization