UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015381
Receipt number R000017902
Scientific Title Effects of dipeptidyl peptidase-4 (DPP-4) inhibitor, alogliptin, on coronary atherosclerosis in patients with type 2 diabetes mellitus
Date of disclosure of the study information 2014/10/09
Last modified on 2018/10/15 18:27:19

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Basic information

Public title

Effects of dipeptidyl peptidase-4 (DPP-4) inhibitor, alogliptin, on coronary atherosclerosis in patients with type 2 diabetes mellitus

Acronym

Effects of dipeptidyl peptidase-4 (DPP-4) inhibitor, alogliptin, on coronary atherosclerosis in patients with type 2 diabetes mellitus

Scientific Title

Effects of dipeptidyl peptidase-4 (DPP-4) inhibitor, alogliptin, on coronary atherosclerosis in patients with type 2 diabetes mellitus

Scientific Title:Acronym

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

1st name
Middle name
Last name Ichiro Michishita

Organization

Yokohama Sakae Kyosai Hospital

Division name

Division of Cardiology, Department of Internal Medicine

Zip code


Address

132 Katsura-cho, Sakae-ku, Yokohama

TEL

045-891-2171

Email

i-michishita@yokohamasakae.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tsuyoshi Nozue

Organization

Yokohama Sakae Kyosai Hospital

Division name

Division of Cardiology, Department of Internal Medicine

Zip code


Address

132 Katsura-cho, Sakae-ku, Yokohama

TEL

045-891-2171

Homepage URL


Email

nozue2493@yahoo.co.jp


Sponsor or person

Institute

Kanagawa PTCA Conference

Institute

Department

Personal name



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)



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



Other administrative information

Date of disclosure of the study information

2014 Year 10 Month 09 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


Results date posted


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

2014 Year 09 Month 24 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017902


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name