UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of one of antidiabetic agents, teneligliptin, on the vascular endothelium function of ACS patients with diabetes
Title of the study (Brief title)	Effects of one of antidiabetic agents, teneligliptin, on the vascular endothelium function of ACS patients with diabetes
Region	Japan

Condition
Condition	Acute Coronary Syndrome (ACS) and diabetes
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess effects of teneligliptin on blood glucose and lipid metabolism as well as serum DPP-4 concentration, serum SDF1-alpha concentration, EPC induction, vascular endothelium function, expansion and contraction of myocardium, and coronary artery lesion
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. Count of peripheral blood EPCs (at time of pre-treatment/0 week, and 28 weeks after intervention) 2. Serum DPP-4 activity (at time of pre-treatment/0 week, and 28 weeks after intervention) 3. Serum SDF1-alpha concentration (at time of pre-treatment/0 week, and 28 weeks after intervention)
Key secondary outcomes	1. Assessment of vascular endothelium function by FMD 2. Heart function test, expansionability, by echocardiography (E/A ratio and e/e' ratio of mitral annulus) 3. Cardiac catheter test, IVUS for coronary artery lesion: plaque cross-sectional area of the lesion 4. Blood glucose level (fasting, postprandial [2 hours from a meal], HbA1c) 5. Serum lipid parameter: fasting serum triglyceride, LDL, HDL, fatty acid 4-fractions, RLP, and Lp(a) 6. Urinary 8-OHdG

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Group A: Teneligliptin group (20mg tablet once a day for 28 weeks)
Interventions/Control_2	Group B: Control group (regular treatment)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Only those patients who meet all of the following criteria are included in this study: 1. Newly start using a DPP-4 inhibitor 2. Hospitalized due to ACS (max CPK is not over 1000, and heart function is not damaged) and underwent angioplasty 3. No restriction for age and gender 4. Mild diabetes mellitus: casual blood glucose 200 mg/dL level, or HbA1c < 7% 5. In combination of using other medication, such as aspirin, statin, etc. are allowed under a condition that antihyperglycemic agents such as BG, alpha-glucosidase inhibitor, SU, glinide, etc. are not used. 6. Fully understand the purpose of the study after an explanation given by a researcher, and are able to provide their written consent by their free will to participate in this study
Key exclusion criteria	For those who fall into any of the following criteria are excluded from the study: 1. With a condition of significantly elevated blood glucose, multiple medication or insulin treatment is desirable 2. The CPK level is over 1000 after ACS onset with suspected cardiomyopathy 3. With medical history of heart disease 4. With sever ketoacidosis, diabetic coma, or precoma 5. Serious infection 6. Perioperative 7. Serious physical injury 8. Showing hypersensitiveness to any compound of teneligliptin 9. Other conditions where the patient is judged by a physician to be inappropriate to participate in the study
Target sample size	50

Research contact person
Name of lead principal investigator	Tomio Umemoto
Organization	Saitama Medical Center, Jichi Medical University
Division name	Division of Cardiovascular Medicine
Address	1-847 Amanumacho, Omiyaku, Saitama-city, Saitama, Japan 330-8503
TEL	048-647-2111
Email	sugayoshi1@jichi.ac.jp

Public contact
Name of contact person	Hiroki Takayama
Organization	Soiken Inc.
Division name	Division of Clinical Study Support
Address	NBF Bld. 4th Floor, 1-3-1 Ogawamachi, Kanda, Chiyoda-ku, Tokyo
TEL	03-3295-1350
Homepage URL
Email	takayama@soiken.com

Sponsor
Institute	Saitama Medical Center, Jichi Medical University
Institute
Department

Funding Source
Organization	Mitsubishi Tanabe Pharma Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	自治医科大学附属さいたま医療センター Saitama Medical Center, Jichi Medical University

Other administrative information
Date of disclosure of the study information	2015 Year 09 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 03 Month 03 Day
Anticipated trial start date	2015 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 09 Month 08 Day
Last modified on	2019 Year 03 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021223