TOPLEVEL study

Phase 4

• Conditions: Type 2 Diabetes Mellitus

• Registration Number: JPRN-jRCTs051180136
• Lead Sponsor: Kitakaze Masafumi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-18
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 936

Inclusion Criteria

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

Exclusion Criteria

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
11) Patients judged to be unsuitable for the study as they may drink excessively or abuse drugs
12) Patients with a prior history of ileus
13)Patients showing QT prolongation in the electrocardiogram
14) Patients with any past histories of heart failure showing NYHA classification grade more than 3 at baseline
15) Patients with any past histories of acute coronary syndrome or coronary intervention or cardiac surgery developed within 6 months
16) Patients with any surgical past histories of mitral valve replacement or mitral valve repair or severe calcification of mitral valve
17) Patients already treated with Teneligliptin
18) Patients who have already received DPP-4 inhibitors and are not able to change these drug
19) Women with breast-feeding
20) Pregnant women or patients who have possibilities of pregnancy
21) Patients expected to live less than 3 years
22)Patients with any past histories of drug hypersensitivity against Teneligliptin
23) Patients already involved in any other interventional clinical trials or planned to be involved
24) Patients judged to be inappropriate for the study by the doctors in charge

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change of the ratio of peak velocity of early transmitral diastolic filling by echocardiography (E) to early diastolic mitral annular velocity by tissue Doppler echocardiography (E/e') for 2 years from baseline.