UMIN-CTR Clinical Trial

Basic information
Public title	The effects of a DPP4 inhibitor on endothelial function in diabetic patients with coronary artery disease
Acronym	The effects of a DPP4 inhibitor on endothelium
Scientific Title	The effects of a DPP4 inhibitor on endothelial function in diabetic patients with coronary artery disease
Scientific Title:Acronym	The effects of a DPP4 inhibitor on endothelium
Region	Japan

Condition
Condition	Type 2 diabetes mellitus with coronary artery disease
Classification by specialty	Cardiology Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate whether DPP4 inhibitors could improve endothelial dysfunctions in diabetic patients with coronary artery disease
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Reactive hyperemia peripheral arterial tonometry index
Key secondary outcomes	High-sensitivity C-reactive Protein

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -but assessor(s) are 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	Additional treatment of Sitagliptin
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	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Type 2 diabetes mellitus (DM) patients with coronary artery disease 1. Uncontrolled DM patients with diet and exercise therapy 2. Uncontrolled DM patients treated with insulin injections or oral anti-diabetic drugs except DPP-4 inhibitors Patients with coronary artery disease documented by CAG or CT with organic coronary stenosis of >50% in major coronary arteries.
Key exclusion criteria	1. Patients receiving GLP-1 receptor analogues injection and glinide drugs 2. Patients needed rapidly intensive glucose control 3. Patients with heart failure (New York Heart Association functional class II to IV) 4. Patients with active systemic inflammatory disease, chronic renal failure requiring hemodialysis, active hepatic disease, and presence of malignant tumor 5. Patients with acute coronary syndrome within 3 months preceding admission 6. Ineligible patients for any other reasons
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Junichi Matsubara
Organization	Kumamoto University, Faculty of Life Sciences
Division name	Department of Cardiovascular Medicine
Zip code
Address	1-1-1 Honjo, Chuo-ku, Kumamoto City
TEL	096-353-5175
Email	j-matsu@kumamoto-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Junichi Matsubara
Organization	Kumamoto University, Faculty of Life Sciences
Division name	Department of Cardiovascular Medicine
Zip code
Address	1-1-1 Honjo, Chuo-ku, Kumamoto City
TEL	096-373-5175
Homepage URL
Email	j-matsu@kumamoto-u.ac.jp

Sponsor
Institute	Department of Cardiovascular Medicine, Faculty of Life Sciences, Kumamoto University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	熊本大学医学部附属病院（熊本県）

Other administrative information
Date of disclosure of the study information	2012 Year 08 Month 30 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date	2011 Year 01 Month 01 Day
Last follow-up date	2012 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2012 Year 08 Month 30 Day
Last modified on	2015 Year 03 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010343

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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