UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of Teneligliptin improvement endotherial dysfunction, inflammation, coagulation and oxidative stress in patients with coronary artery disease and diabetes, pilot study(Tiramisu study).
Title of the study (Brief title)	Tiramisu study
Region	Japan

Condition
Condition	Coronary artery disease
Classification by specialty	Cardiology Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Efficacy of DPP4 inhibitor in patients with coronary artery diesease and diabetes.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	improvement of endothelial function
Key secondary outcomes	HbA1c,Glycated albumin,1.5-anhydro-D-glucitol,fasting plasma glucose, immunoreactive insulin, HOMA-IR, HOMA-beta, hs-CRP, IL-6, MCP-1, TNF-alpha Red blood cell, White blood cell, platelet, D dimer, FDP, fibrinogen, 8-OHdG, BNP, body weight

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Teneligliptin
Interventions/Control_2
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Diabetic patients with coronary artery disease
Key exclusion criteria	Type I diabetes
Target sample size	30

Research contact person
Name of lead principal investigator	Murata Makoto
Organization	Gunma University Graduate School of Medicine
Division name	Department of Medicine and Biological Science
Address	3-39-15.Showa-Machi,Maebashi-Shi,Gunma-Ken,JAPAN
TEL	+81-27-220-8153
Email	yarukimanmann2000@yahoo.co.jp

Public contact
Name of contact person	Murata Makoto
Organization	Gunma University
Division name	Division of Cardiology
Address	3-39-15.Showa-Machi,Maebashi-Shi,Gunma-Ken
TEL	027-220-7111
Homepage URL
Email	yarukimanmann2000@yahoo.co.jp

Sponsor
Institute	Gunma University
Institute
Department

Funding Source
Organization	Gunma University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	JAPAN

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	群馬大学

Other administrative information
Date of disclosure of the study information	2013 Year 10 Month 05 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 09 Month 05 Day
Anticipated trial start date	2013 Year 10 Month 05 Day
Last follow-up date	2017 Year 06 Month 03 Day
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	2013 Year 10 Month 04 Day
Last modified on	2017 Year 06 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013972