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

August 20, 2018 updated by: Masafumi Kitakaze, National Cerebral and Cardiovascular Center

Clinical Study for the Effect of Teneligliptin on the Left Ventricular Diastolic Dysfunction in Patients With Type 2 Diabetes Mellitus

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
936

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Miki Imazu, M.D., Ph.D.
  • Phone Number: 2225 81-6-6833-5012
  • Email: mimadu@ncvc.go.jp

Study Locations

  • Japan
      • Suita, Japan, 565-8565
        • Recruiting
        • National Cerebral and Cardiovascular Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Teneligliptin in the inhibition test
Patients showing E/e' by echocardiography less than 8 at base line and assigned as Teneligliptin treatment by randomization
Drug: Teneligliptin
No Intervention: 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
Experimental: Teneligliptin in the improvement test
Patients showing E/e' by echocardiography more than 8 at base line and assigned as Teneligliptin treatment by randomization
Drug: Teneligliptin
No Intervention: 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
Up to 2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Total number of all-cause death
Time Frame: Up to 2 years
Up to 2 years
Total number of deaths by cardiovascular events
Time Frame: Up to 2 years
Up to 2 years
Total number of all-cause hospitalization
Time Frame: Up to 2 years
Up to 2 years
Total number of hospitalization by cardiovascular events
Time Frame: Up to 2 years
Up to 2 years
Total number of hospitalization by progression of heart failure
Time Frame: Up to 2 years
Up to 2 years
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
Up to 2 years
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
Up to 2 years
Change of the deceleration time (DT) by echocardiography
Time Frame: Up to 2 years
Up to 2 years
Change of the left atrium volume (LAV) by echocardiography
Time Frame: Up to 2 years
Up to 2 years
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
Up to 2 years
Change of the left ventricular mass index (LVMI) by echocardiography
Time Frame: Up to 2 years
Up to 2 years
Change of NYHA functional class
Time Frame: Up to 2 years
Up to 2 years
Change of plasma levels of NT-proBNP
Time Frame: Up to 2 years
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Cerebral and Cardiovascular Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 17, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 20, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 22, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M26-43

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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