UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005238
Receipt number R000006228
Scientific Title The effect of Sitagliptin on Coronary Flow Reserve in Type 2 Diabetic Patients with Coronary Artery Disease
Date of disclosure of the study information 2011/03/11
Last modified on 2024/03/21 12:59:00

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Basic information

Public title

The effect of Sitagliptin on Coronary Flow Reserve in Type 2 Diabetic Patients with Coronary Artery Disease

Acronym

The effect of Sitagliptin on Coronary Flow Reserve

Scientific Title

The effect of Sitagliptin on Coronary Flow Reserve in Type 2 Diabetic Patients with Coronary Artery Disease

Scientific Title:Acronym

The effect of Sitagliptin on Coronary Flow Reserve

Region

Japan


Condition

Condition

Type 2 Diabetic Patients with Coronary Artery Disease

Classification by specialty

Cardiology Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effect of the DPP-4 Inhibitor "Sitagliptin" on coronary flow reserve in type 2 diabetic patients with coronary artery disease

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Coronary flow reserve by coronary flow wire

Key secondary outcomes

1,5-AG, CAVI, FMD, MMP-9, PTX3


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

Add-on Stagliptin

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

80 years-old >

Gender

Male and Female

Key inclusion criteria

1)Type2 diabetic patients with coronary artery disease.(HbA1c >=6.5% JDS)
2)Age >=20 years, <80 years (Male and Female)
3)A consent form for participating in this study is submitted

Key exclusion criteria

1)Patients with type 1 diabetes
2)Patients receiving Alfa-glycosidase inhibitor, Insulin or Glinide
3)History of severe ketosis, diabetic coma or precoma within 6 months
4)Patients with severe infections, before or after operation, or with serious trauma
5)Patients who are pregnant, breastfeeding or intention to becoming pregnant
6)Patients with exceeding the moderate renal impairment
7)Having allergy to DPP-4 Inhibitor
8)Patients with significant stenosis at major 3 coronary artery or with history for PCI
9)Other patients determined to be inappropriate by physician

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Hiroyasu
Middle name
Last name Uzui

Organization

University of Fukui, Faculty of Medical Sciences

Division name

Division of cardiovascular Medicine

Zip code

9101193

Address

23-3 Shimoaizuki, Eiheiji-cho, Fukui 910-1193, Japan.

TEL

0776-61-3111

Email

huzui@u-fukui.ac.jp


Public contact

Name of contact person

1st name Hiroyasu
Middle name
Last name Uzui

Organization

University of Fukui, Faculty of Medical Sciences

Division name

Division of cardiovascular Medicine

Zip code

9101193

Address

23-3 Shimoaizuki, Eiheiji-cho, Fukui 910-1193, Japan.

TEL

0776-61-3111

Homepage URL


Email

huzui@u-fukui.ac.jp


Sponsor or person

Institute

University of Fukui Faculty of Medical Sciences, Division of cardiovascular Medicine

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

University of Fukui Medical Reseach Support Center

Address

23-3 Shimoaizuki Matsuoka-cho Eiheiji Fukui Japan

Tel

0776-61-3111

Email

chiken@ml.u-fukui.ac.jp


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

福井大学医学部附属病院


Other administrative information

Date of disclosure of the study information

2011 Year 03 Month 11 Day


Related information

URL releasing protocol

none

Publication of results

Unpublished


Result

URL related to results and publications

none

Number of participants that the trial has enrolled

24

Results

Recruitment of participants

Results date posted

2024 Year 03 Month 21 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Recruitment of participants

Participant flow

Recruitment of participants

Adverse events

none

Outcome measures

Recruitment of participants

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Preinitiation

Date of protocol fixation

2011 Year 01 Month 18 Day

Date of IRB


Anticipated trial start date

2011 Year 03 Month 01 Day

Last follow-up date

2013 Year 12 Month 01 Day

Date of closure to data entry

2014 Year 06 Month 01 Day

Date trial data considered complete

2014 Year 06 Month 01 Day

Date analysis concluded

2014 Year 06 Month 01 Day


Other

Other related information



Management information

Registered date

2011 Year 03 Month 11 Day

Last modified on

2024 Year 03 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006228


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name