UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of dipeptidyl peptidase-4 (DPP-4) inhibitor, alogliptin, on coronary atherosclerosis in patients with type 2 diabetes mellitus
Title of the study (Brief title)	Effects of dipeptidyl peptidase-4 (DPP-4) inhibitor, alogliptin, on coronary atherosclerosis in patients with type 2 diabetes mellitus
Region	Japan

Condition
Condition	Patients with type 2 diabetes mellitus who were suspected as having ischemic heart disease
Classification by specialty	Medicine in general Cardiology Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effects of DPP-4 inhibitor, alogliptin, on coronary atherosclerosis evaluated by coronary computed tomography angiography (CCTA)in patients with type 2 diabetes mellitus
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change of FFR evaluated by CCTA (FFRCT)
Key secondary outcomes	Change in plaque volume evaluated by CCTA Change in CT values evaluated by CCTA

Base
Study type

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	Alogliptin
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	(1)Patients with type 2 diabetes mellitus(2)Patients as having mild atherosclerosis (diameter stenosis less than 50%) evaluated by CCTA at baseline (3)Patients who are judged by physician to administrate alogliptin
Key exclusion criteria	(1)Patients who are suspected as having significant stenosis evaluated by CCTA and require to receive percutaneous coronary intervention (PCI) (2)Patients with acute coronary syndrome within 30 days (3)Patients with the past history of PCI(4)Patients with post coronary artery bypass grafting (CABG) (5)Patients with complex congenital heart disease (6)Patients with body mass index >35kg/m2 (7)Patients with the past history of heart failure (8)Patients with the past history of ketoacidosis or diabetic coma (9)Patients with hepatic disorder or with AST (GOT) or ALT (GPT) greater than 2 times of the upper limits of normal (10)Patients with renal dysfunction (estimated glomerular filtration rate 30 ml/min/1.73m2 or lower) (11)Patients with severe infection, pre or post operation, or severe trauma (12)Patients with a history of hypersensitivity to any of the components of alogliptin (13)Pregnant women, women suspected of being pregnant, or lactating women (14)Patients ineligible for the study determined by physicians
Target sample size	50

Research contact person
Name of lead principal investigator	Ichiro Michishita
Organization	Yokohama Sakae Kyosai Hospital
Division name	Division of Cardiology, Department of Internal Medicine
Address	132 Katsura-cho, Sakae-ku, Yokohama
TEL	045-891-2171
Email	i-michishita@yokohamasakae.jp

Public contact
Name of contact person	Tsuyoshi Nozue
Organization	Yokohama Sakae Kyosai Hospital
Division name	Division of Cardiology, Department of Internal Medicine
Address	132 Katsura-cho, Sakae-ku, Yokohama
TEL	045-891-2171
Homepage URL
Email	nozue2493@yahoo.co.jp

Sponsor
Institute	Kanagawa PTCA Conference
Institute
Department

Funding Source
Organization	Japana Diabetes Foundation
Organization
Division
Category of Funding Organization	Non profit foundation
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	2014 Year 10 Month 09 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 09 Month 24 Day
Anticipated trial start date	2014 Year 10 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	Published
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 10 Month 09 Day
Last modified on	2018 Year 10 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017902