Diabetes Mellitus, Type 2Phase 4TOPLEVELNCT02449330
Teneligliptin on the Progressive Left Ventricular Diastolic Dysfunction With Type 2 Diabetes Mellitus Study
A Phase 4 study testing Teneligliptin in people with Diabetes Mellitus, Type 2, run by National Cerebral and Cardiovascular Center, Japan at 1 site in Japan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Teneligliptin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 936 participants
- Where
- 1 siteJapan
- Study dates
- Jun 2015to Jun 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Asians aged from 20 to 85 years old at baseline
- Patients with type 2 diabetes mellitus and including either A) or B) criteria.
- Patients necessary to start the treatment using anti-diabetic agent(s) or to change the anti-diabetic agent(s).
- Patients possible to change the anti-diabetic agent(s).
- Patients with left ventricular ejection fraction more than 40%
- Patients with written informed consent
Who cannot join
- 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
Show all 22Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
National Cerebral and Cardiovascular Center
Suita, 565-8565
Satoshi Yasuda, M.D., 06-6833-5012, yasuda.satoshi.hp@ncvc.go.jp
About this study
Official title: 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Teneligliptin
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeneligliptinDrug
| Study group | Role | What they receive |
|---|---|---|
| Teneligliptin in the inhibition test | Experimental | Patients showing E/e' by echocardiography less than 8 at base line and assigned as Teneligliptin treatment by randomization Receives: Drug: Teneligliptin |
| Other agents in the inhibition test | No intervention | 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 |
| Teneligliptin in the improvement test | Experimental | Patients showing E/e' by echocardiography more than 8 at base line and assigned as Teneligliptin treatment by randomization Receives: Drug: Teneligliptin |
| Other agents in the improvement test | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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')
Measured: Up to 2 years
Secondary outcomes (13)
Total number of all-cause death
Measured: Up to 2 years
Total number of deaths by cardiovascular events
Measured: Up to 2 years
Total number of all-cause hospitalization
Measured: Up to 2 years
Total number of hospitalization by cardiovascular events
Measured: Up to 2 years
Total number of hospitalization by progression of heart failure
Measured: Up to 2 years
Total number of incidents for the addition or increase of the agents for heart failure by progression of heart failure
Measured: 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
Measured: Up to 2 years
Change of the deceleration time (DT) by echocardiography
Measured: Up to 2 years
Change of the left atrium volume (LAV) by echocardiography
Measured: 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
Measured: Up to 2 years
Change of the left ventricular mass index (LVMI) by echocardiography
Measured: Up to 2 years
Change of NYHA functional class
Measured: Up to 2 years
Change of plasma levels of NT-proBNP
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2015 (estimated)
- Study startJun 2015
- Primary completionJun 2020 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 936 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cerebral and Cardiovascular Center, Japan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Masafumi Kitakaze, National Cerebral and Cardiovascular Center, Japan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02449330
- Sponsor's protocol ID
- M26-43
- Acronym
- TOPLEVEL
- Status last verified
- Aug 2018
- First submitted
- 17 May 2015
- Last updated
- 22 Aug 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study for the Effect of Teneligliptin on the Left Ventricular Diastolic Dysfunction in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02449330
- Acronym / sponsor ID
- TOPLEVEL / M26-43
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 936 participants (estimated)
- Lead sponsor
- National Cerebral and Cardiovascular Center, JapanUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 20 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Teneligliptin in the inhibition test | Experimental | Drug: TeneligliptinPatients 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 intervention | –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 |
| Teneligliptin in the improvement test | Experimental | Drug: TeneligliptinPatients 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 intervention | –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 |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Asians aged from 20 to 85 years old at baseline
- Patients with type 2 diabetes mellitus and including either A) or B) criteria.
- Patients necessary to start the treatment using anti-diabetic agent(s) or to change the anti-diabetic agent(s).
- Patients possible to change the anti-diabetic agent(s).
- Patients with left ventricular ejection fraction more than 40%
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Teneligliptin | Drug | Teneligliptin in the improvement test, Teneligliptin in the inhibition test |
Primary outcome
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
13 secondary outcomes
Total number of all-cause death
Time frame: Up to 2 years
Total number of deaths by cardiovascular events
Time frame: Up to 2 years
Total number of all-cause hospitalization
Time frame: Up to 2 years
Total number of hospitalization by cardiovascular events
Time frame: Up to 2 years
Total number of hospitalization by progression of heart failure
Time frame: 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
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
Change of the deceleration time (DT) by echocardiography
Time frame: Up to 2 years
Change of the left atrium volume (LAV) by echocardiography
Time frame: 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
Change of the left ventricular mass index (LVMI) by echocardiography
Time frame: Up to 2 years
Change of NYHA functional class
Time frame: Up to 2 years
Change of plasma levels of NT-proBNP
Time frame: Up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Teneligliptin in people with Diabetes Mellitus, Type 2, run by National Cerebral and Cardiovascular Center, Japan at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Miki Imazu, M.D., Ph.D. (81-6-6833-5012 ext. 2225, mimadu@ncvc.go.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2018.