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

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ClinicalTrials.gov Identifier: NCT02449330
Recruitment Status : Recruiting
First Posted : May 20, 2015
Last Update Posted : August 22, 2018
Sponsor:
Information provided by (Responsible Party):
Masafumi Kitakaze, National Cerebral and Cardiovascular Center

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Teneligliptin Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 936 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Study for the Effect of Teneligliptin on the Left Ventricular Diastolic Dysfunction in Patients With Type 2 Diabetes Mellitus
Study Start Date : June 2015
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 Measures :
  1. Total number of all-cause death [ Time Frame: Up to 2 years ]
  2. Total number of deaths by cardiovascular events [ Time Frame: Up to 2 years ]
  3. Total number of all-cause hospitalization [ Time Frame: Up to 2 years ]
  4. Total number of hospitalization by cardiovascular events [ Time Frame: Up to 2 years ]
  5. Total number of hospitalization by progression of heart failure [ Time Frame: Up to 2 years ]
  6. 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 ]
  7. 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 ]
  8. Change of the deceleration time (DT) by echocardiography [ Time Frame: Up to 2 years ]
  9. Change of the left atrium volume (LAV) by echocardiography [ Time Frame: Up to 2 years ]
  10. 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 ]
  11. Change of the left ventricular mass index (LVMI) by echocardiography [ Time Frame: Up to 2 years ]
  12. Change of NYHA functional class [ Time Frame: Up to 2 years ]
  13. Change of plasma levels of NT-proBNP [ Time Frame: Up to 2 years ]


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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02449330


Contacts
Contact: Miki Imazu, M.D., Ph.D. 81-6-6833-5012 ext 2225 mimadu@ncvc.go.jp

Locations
Japan
National Cerebral and Cardiovascular Center Recruiting
Suita, Japan, 565-8565
Contact: Satoshi Yasuda, M.D.    06-6833-5012    yasuda.satoshi.hp@ncvc.go.jp   
Sponsors and Collaborators
National Cerebral and Cardiovascular Center

Responsible Party: Masafumi Kitakaze, Director, National Cerebral and Cardiovascular Center
ClinicalTrials.gov Identifier: NCT02449330     History of Changes
Other Study ID Numbers: M26-43
First Posted: May 20, 2015    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 2018

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Ventricular Dysfunction, Left
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Ventricular Dysfunction
Heart Diseases
Cardiovascular Diseases