Clinical Study for the Effect of Teneligliptin on the Progressive Left Ventricular Diastolic Dysfunction in Patients with Type 2 Diabetes Mellitus
- Conditions
- Type 2 Diabetes Mellitus
- Registration Number
- JPRN-UMIN000014589
- Lead Sponsor
- TOPLEVEL study office
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 936
Not provided
- 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
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
- Secondary Outcome Measures
Name Time Method