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Teneligliptin on the Progressive Left Ventricular Diastolic Dysfunction With Type 2 Diabetes Mellitus Study (TOPLEVEL)

Primary Purpose

Diabetes Mellitus, Type 2

Status
Unknown status
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Teneligliptin
Sponsored by
National Cerebral and Cardiovascular Center, Japan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

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 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

Sites / Locations

  • National Cerebral and Cardiovascular CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Experimental

No Intervention

Arm Label

Teneligliptin in the inhibition test

Other agents in the inhibition test

Teneligliptin in the improvement test

Other agents in the improvement test

Arm Description

Patients showing E/e' by echocardiography less than 8 at base line and assigned as Teneligliptin treatment by randomization

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

Patients showing E/e' by echocardiography more than 8 at base line and assigned as Teneligliptin treatment by randomization

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

Outcomes

Primary Outcome Measures

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')

Secondary Outcome Measures

Total number of all-cause death
Total number of deaths by cardiovascular events
Total number of all-cause hospitalization
Total number of hospitalization by cardiovascular events
Total number of hospitalization by progression of heart failure
Total number of incidents for the addition or increase of the agents for heart failure by progression of heart failure
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
Change of the deceleration time (DT) by echocardiography
Change of the left atrium volume (LAV) by echocardiography
Change of the left ventricular end-diastolic diameter (LVDd), left ventricular end-systolic diameter (LVDs) and fractional shortening (%FS) by echocardiography
Change of the left ventricular mass index (LVMI) by echocardiography
Change of NYHA functional class
Change of plasma levels of NT-proBNP

Full Information

First Posted
May 17, 2015
Last Updated
August 20, 2018
Sponsor
National Cerebral and Cardiovascular Center, Japan
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1. Study Identification

Unique Protocol Identification Number
NCT02449330
Brief Title
Teneligliptin on the Progressive Left Ventricular Diastolic Dysfunction With Type 2 Diabetes Mellitus Study
Acronym
TOPLEVEL
Official Title
Clinical Study for the Effect of Teneligliptin on the Left Ventricular Diastolic Dysfunction in Patients With Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cerebral and Cardiovascular Center, Japan

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
936 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Teneligliptin in the inhibition test
Arm Type
Experimental
Arm Description
Patients showing E/e' by echocardiography less than 8 at base line and assigned as Teneligliptin treatment by randomization
Arm Title
Other agents in the inhibition test
Arm Type
No Intervention
Arm Description
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
Arm Title
Teneligliptin in the improvement test
Arm Type
Experimental
Arm Description
Patients showing E/e' by echocardiography more than 8 at base line and assigned as Teneligliptin treatment by randomization
Arm Title
Other agents in the improvement test
Arm Type
No Intervention
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Teneligliptin
Primary Outcome Measure Information:
Title
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')
Time Frame
Up to 2 years
Secondary Outcome Measure Information:
Title
Total number of all-cause death
Time Frame
Up to 2 years
Title
Total number of deaths by cardiovascular events
Time Frame
Up to 2 years
Title
Total number of all-cause hospitalization
Time Frame
Up to 2 years
Title
Total number of hospitalization by cardiovascular events
Time Frame
Up to 2 years
Title
Total number of hospitalization by progression of heart failure
Time Frame
Up to 2 years
Title
Total number of incidents for the addition or increase of the agents for heart failure by progression of heart failure
Time Frame
Up to 2 years
Title
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
Time Frame
Up to 2 years
Title
Change of the deceleration time (DT) by echocardiography
Time Frame
Up to 2 years
Title
Change of the left atrium volume (LAV) by echocardiography
Time Frame
Up to 2 years
Title
Change of the left ventricular end-diastolic diameter (LVDd), left ventricular end-systolic diameter (LVDs) and fractional shortening (%FS) by echocardiography
Time Frame
Up to 2 years
Title
Change of the left ventricular mass index (LVMI) by echocardiography
Time Frame
Up to 2 years
Title
Change of NYHA functional class
Time Frame
Up to 2 years
Title
Change of plasma levels of NT-proBNP
Time Frame
Up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Miki Imazu, M.D., Ph.D.
Phone
81-6-6833-5012
Ext
2225
Email
mimadu@ncvc.go.jp
Facility Information:
Facility Name
National Cerebral and Cardiovascular Center
City
Suita
ZIP/Postal Code
565-8565
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Satoshi Yasuda, M.D.
Phone
06-6833-5012
Email
yasuda.satoshi.hp@ncvc.go.jp

12. IPD Sharing Statement

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Teneligliptin on the Progressive Left Ventricular Diastolic Dysfunction With Type 2 Diabetes Mellitus Study

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