Teneligliptin on the Progressive Left Ventricular Diastolic Dysfunction With Type 2 Diabetes Mellitus Study
TOPLEVEL
Clinical Study for the Effect of Teneligliptin on the Left Ventricular Diastolic Dysfunction in Patients With Type 2 Diabetes Mellitus
1 other identifier
interventional
936
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 diabetes-mellitus-type-2
Started Jun 2015
Longer than P75 for phase_4 diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2015
CompletedFirst Posted
Study publicly available on registry
May 20, 2015
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedAugust 22, 2018
August 1, 2018
5 years
May 17, 2015
August 20, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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')
Up to 2 years
Secondary Outcomes (13)
Total number of all-cause death
Up to 2 years
Total number of deaths by cardiovascular events
Up to 2 years
Total number of all-cause hospitalization
Up to 2 years
Total number of hospitalization by cardiovascular events
Up to 2 years
Total number of hospitalization by progression of heart failure
Up to 2 years
- +8 more secondary outcomes
Study Arms (4)
Teneligliptin in the inhibition test
EXPERIMENTALPatients showing E/e' by echocardiography less than 8 at base line and assigned as Teneligliptin treatment by randomization
Other agents in the inhibition test
NO INTERVENTIONPatients 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
EXPERIMENTALPatients showing E/e' by echocardiography more than 8 at base line and assigned as Teneligliptin treatment by randomization
Other agents in the improvement test
NO INTERVENTIONPatients 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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Cerebral and Cardiovascular Center
Suita, 565-8565, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
May 17, 2015
First Posted
May 20, 2015
Study Start
June 1, 2015
Primary Completion
June 1, 2020
Study Completion
June 1, 2023
Last Updated
August 22, 2018
Record last verified: 2018-08