UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Exploratory study on the cardiovascular system of DPP-4 inhibitors in angina patients underwent PCI after complicated with type 2 diabetes
Title of the study (Brief title)	Exploratory study on the cardiovascular system of DPP-4 inhibitors in angina patients underwent PCI after complicated with type 2 diabetes
Region	Japan

Condition
Condition	Type 2 diabetic patients with angina pectoris who undergo percutaneous coronary intervention
Classification by specialty	Cardiology Cardiovascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This is an exploratory study of DPP-4 inhibitor aiming to evaluate the co-relationship between plasma glucose reduction and the change of plaque volume and virtual histology of non-target vascular wall in type 2 diabetic patients with angina.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase IV

Assessment
Primary outcomes	1) The change of HbA1 at baseline and 8months after DPP-4 inhibitor treatment. 2) The change of plaque volume of non-culprit lesion at 8 months after PCI. 3) The change of virtual histology of non-culprit lesion segment at 8 months after PCI. 4) The co-relationship between HbA1c redaction and the change of plaque volume
Key secondary outcomes	1) Plasma glucose 2) Serum lipids 3) Peripheral blood CD-34 positive cells 4) High sensitive CRP 5) BNP 6) Blood pressure 7) Body weight 8) Safety

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	DPP-4 inhibitor
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	30 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	1) Type 2 diabetes mellitus (HbA1c: 7.0-9.0%) 2) Patients treated PCI 3) Written consent for participation in this study 4) Patients with the age between 30-80 years old male and female at the written consent
Key exclusion criteria	1) Type 1 diabetes mellitus 2) Severe diabetic ketosis, diabetic coma or total coma within 6 months 3) Patients who have 90% or more of the stenosis without PCI culprit lesion 4) Undergoing hemodialysis 5) Severe infectious disease ,before or after surgery, and sever trauma 6) Occurrence of ischemic stroke, hemorrhagic stroke or TIA within 6 months 7) Moderate or severe heart failure (NYHA III or IV) 8) Patients who did not receive DPP4 inhibitors during 3 month before starting study 9) Under treatment with insulin 10) Pregnant,lactating, possibly pregnant or planning to become pregnant women 11) Past medical history of hypersensitivity to linagliptin 12) Patients considered as inadequate by the principal investigator
Target sample size	20

Research contact person
Name of lead principal investigator	Seiji Yamazaki
Organization	Center for Clinical and Biomedical Research,Sapporo Higashi Tokushukai Hospital
Division name	Cardiovascular Research Department
Address	14-3-1, Kita 33-jyo Higashi, Higashi-ku, Sapporo, Hokkaido
TEL	011-722-1110
Email	kenkyu@tohtoku.jp

Public contact
Name of contact person	kiyotaka takeda
Organization	Center for Clinical and Biomedical Research, Sapporo Higashi Tokushukai Hospital
Division name	Clinical Research
Address	14-3-1, Kita 33-jyo Higashi, Higashi-ku, Sapporo, Hokkaido
TEL	011-722-5820
Homepage URL
Email	yakyoku@higashi-tokushukai.or.jp

Sponsor
Institute	Center for Clinical and Biomedical Research, Sapporo Higashi Tokushukai Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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	医療法人 徳洲会 札幌東徳洲会病院（北海道）

Other administrative information
Date of disclosure of the study information	2013 Year 07 Month 19 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 07 Month 03 Day
Anticipated trial start date	2013 Year 07 Month 08 Day
Last follow-up date	2016 Year 06 Month 30 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 07 Month 08 Day
Last modified on	2016 Year 07 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012496