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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014589
Receipt No. R000016974
Scientific Title Clinical Study for the Effect of Teneligliptin on the Progressive Left Ventricular Diastolic Dysfunction in Patients with Type 2 Diabetes Mellitus
Date of disclosure of the study information 2014/08/01
Last modified on 2019/01/29

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Basic information
Public title Clinical Study for the Effect of Teneligliptin on the Progressive Left Ventricular Diastolic Dysfunction in Patients with Type 2 Diabetes Mellitus
Acronym TOPLEVEL (Teneligliptin on the Progressive Left Ventricular Diastolic Dysfunction with Type 2 Diabetes Mellitus)
Scientific Title Clinical Study for the Effect of Teneligliptin on the Progressive Left Ventricular Diastolic Dysfunction in Patients with Type 2 Diabetes Mellitus
Scientific Title:Acronym TOPLEVEL (Teneligliptin on the Progressive Left Ventricular Diastolic Dysfunction with Type 2 Diabetes Mellitus)
Region
Japan

Condition
Condition Type 2 Diabetes Mellitus
Classification by specialty
Cardiology Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate whether teneligliptin, one of the Dipeptidyl Peptidase-4 inhibitors, 1) maintain left ventricular diastolic function in patient with type 2 diabetes mellitus showing normal left ventricular diastolic function or 2) improve the progression of left ventricular diastolic dysfunction in patient with type 2 diabetes mellitus showing reduced left ventricular diastolic function by comparing with anti-diabetic agents except for DPP-4 inhibitors in multicenter, randomized, open clinical trial
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes 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
Key secondary outcomes - Total number of all-cause death for 2 years from baseline
- Total number of deaths by cardiovascular events for 2 years from baseline
- Total number of all-cause hospitalization for 2 years from baseline
- Total number of hospitalization by cardiovascular events for 2 years from baseline
- Total number of hospitalization by progression of heart failure for 2 years from baseline
- Total number of incidents for the addition or increase of the agents for heart failure by progression of heart failure for 2 years from baseline
- Change of the ratio of peak velocity of early transmitral diastolic filling (E) to late diastolic filling due to atrial contraction (E/A) by echocardiography for 2 years from baseline
- Change of the deceleration time (DT) by echocardiography for 2 years from baseline
- Change of the left atrium volume (LAV) by echocardiography for 2 years from baseline
- Change of the left ventricular end-diastolic diameter (LVDd), left ventricular end-systolic diameter (LVDs) and fractional shortening (%FS) by echocardiography for 2 years from baseline
- Change of the left ventricular mass index (LVMI) by echocardiography for 2 years from baseline
- Change of NYHA functional class for 2 years from baseline
- Change of plasma levels of NT-proBNP for 2 years from baseline

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 The arm treated by Teneligliptin in the inhibition test

Patients showing E/e' by echocardiography less than 8 at base line and assigned as Teneligliptin treatment by randomization
Interventions/Control_2 The arm treated by anti-diabetic agents except for DPP-4 inhibitors 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
Interventions/Control_3 The arm treated by Teneligliptin in the improvement test

Patients showing E/e' by echocardiography more than 8 at base line and assigned as Teneligliptin treatment by randomization
Interventions/Control_4 The arm treated by Teneligliptin 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
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
85 years-old >
Gender Male and Female
Key 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
Key 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 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
Target sample size 936

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Masafumi Kitakaze
Organization National Cerebral and Cardiovascular Center
Division name Department of Clinical Medicine and Development
Zip code
Address 5-7-1 Fujishirodai, Suita Osaka 565-8565, JAPAN
TEL 06-6833-5012
Email kitakaze@ncvc.go.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Masafumi Kitakaze
Organization National Cerebral and Cardiovascular Center
Division name Department of Clinical Medicine and Development
Zip code
Address 5-7-1 Fujishirodai, Suita Osaka 565-8565, JAPAN
TEL 06-6833-5012
Homepage URL
Email kitakaze@ncvc.go.jp

Sponsor
Institute TOPLEVEL study office
Institute
Department

Funding Source
Organization Mitsubishi Tanabe Pharma
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 国立循環器病研究センター

Other administrative information
Date of disclosure of the study information
2014 Year 08 Month 01 Day

Related information
URL releasing protocol http://www.toplevel.jp/
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2014 Year 05 Month 20 Day
Date of IRB
Anticipated trial start date
2015 Year 06 Month 24 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 07 Month 18 Day
Last modified on
2019 Year 01 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016974

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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