UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014589 |
|---|---|
| Receipt number | 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 | 2020/08/24 15:25:12 |
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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
Name of lead principal investigator
| 1st name | Masafumi |
| Middle name | |
| Last name | Kitakaze |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Clinical Medicine and Development
Zip code
654-8565
Address
6-1 Kishibe-Simmachi, Suita Osaka 564-8565, JAPAN
TEL
06-6170-1070
kitakaze@ncvc.go.jp
Public contact
Name of contact person
| 1st name | Masafumi |
| Middle name | |
| Last name | Kitakaze |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Clinical Medicine and Development
Zip code
564-8565
Address
6-1 Kishibe-Simmachi, Suita Osaka 564-8565, JAPAN
TEL
06-6170-1070
Homepage URL
kitakaze@ncvc.go.jp
Sponsor or person
Institute
TOPLEVEL study office
Institute
Department
Personal name
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
National Cerebral and Cardiovascular Center
Address
6-1 Kishibe-Simmachi, Suita Osaka 564-8565, JAPAN
Tel
06-6170-1070
plandiv@ml.ncvc.go.jp
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
No longer recruiting
Date of protocol fixation
| 2014 | Year | 05 | Month | 20 | Day |
Date of IRB
| 2014 | Year | 06 | Month | 27 | Day |
Anticipated trial start date
| 2015 | Year | 06 | Month | 24 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 30 | Day |
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
| 2020 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016974
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