Teneligliptin on the Progressive Left Ventricular Diastolic Dysfunction With Type 2 Diabetes Mellitus Study
NCT ID: NCT02449330
Last Updated: 2018-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
936 participants
INTERVENTIONAL
2015-06-30
2023-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Teneligliptin in the inhibition test
Patients showing E/e' by echocardiography less than 8 at base line and assigned as Teneligliptin treatment by randomization
Teneligliptin
Other agents in the inhibition test
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
No interventions assigned to this group
Teneligliptin in the improvement test
Patients showing E/e' by echocardiography more than 8 at base line and assigned as Teneligliptin treatment by randomization
Teneligliptin
Other agents in the improvement test
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
No interventions assigned to this group
Interventions
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Teneligliptin
Eligibility Criteria
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Inclusion Criteria
* 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 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
20 Years
85 Years
ALL
No
Sponsors
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National Cerebral and Cardiovascular Center, Japan
OTHER
Responsible Party
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Masafumi Kitakaze
Director
Locations
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National Cerebral and Cardiovascular Center
Suita, , Japan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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M26-43
Identifier Type: -
Identifier Source: org_study_id
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