UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effects of Teneligliptin on vascular inflammatory markers in post-PCI (Percutaneous Coronary Intervention) patients.
Title of the study (Brief title)	The effects of Teneligliptin on vascular inflammatory markers in post-PCI (Percutaneous Coronary Intervention) patients.
Region	Japan

Condition
Condition	Coronary Artery Disease
Classification by specialty	Medicine in general Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify the effects of Teneligliptin on vascular inflammatory markers in PCI patients with T2DM (Type 2 diabetes mellitus).
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Variation amount and rate of inflammatory markers from pretreatment levels.
Key secondary outcomes	Vascular endothelial function: RH-PAT score, variation amount and rate of HbA1c, and glucose from pretreatment levels.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Additional treatment of Teneligliptin
Interventions/Control_2	Conventional 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	30 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	1)Elective PCI patients 2)Patients who have T2DM and HbA1c (NGSP) level are more than 7% before PCI 3)Patients aged 30 up to 80 years old 4)Informed consent was signed by all patients and documented.
Key exclusion criteria	1)Patients with T1DM (type 1 diabetes mellitus) 2)Patients who have medical history of hypersensitivity to diabetes mellitus drugs 3)Patients with medical history of malignant tumor 4)Patients with severe infection, before and after operation, or severe trauma 5)Patients with cardiac arrest (class of III in NYHA) 6)Patients with uncontrolled hypertension 7)Patients with insulin dependent and the potential to change diabetic drugs 8)Patients with severe renal insufficiency (eGFR is less than 30 mL / min / 1.73 m2, dialysis-dependent, or serum creatinine (men, more than 2.5 mg / dL, women, more than 2.0 mg / dL 9) Patients with pregnant, and possibly pregnant 10) Patients with severe ketosis, diabetic coma, or history of coma within the past six months 11)Patients who had stroke, cerebral hemorrhage, subarachnoid hemorrhage, or transient ischemic attack within the past three months. 12)Patients who enrolled into another clinical test within three months prior to this trial 13)Patients who cannot administer antiplatelet drugs 14)Patients who were considered as inappropriate for the study by the investigator.
Target sample size	20

Research contact person
Name of lead principal investigator	Akihiko Matshumura
Organization	Kameda Medhical Center
Division name	Department of Cardiology
Address	929 Higashi-cho Kamogawa City CHiba
TEL	04-7092-2211
Email	matsumura.akihiko@kameda.jp

Public contact
Name of contact person	Aya JUNI
Organization	AsMediX Co., Ltd.
Division name	GPO Department , Business Planning Section
Address	Higashiazabu 1-5-2, Minato-ku, Tokyo
TEL	03-6230-3661
Homepage URL
Email	aya_juni@asmedix.co.jp

Sponsor
Institute	Kameda Medhical Center
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

Other administrative information
Date of disclosure of the study information	2017 Year 05 Month 02 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 10 Month 19 Day
Anticipated trial start date	2017 Year 04 Month 03 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	2017 Year 05 Month 02 Day
Last modified on	2018 Year 11 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029784