UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010486
Receipt number R000012256
Scientific Title The effect by DPP-4 inhibitor for change of blood glucose, vascular endothelial function, and cardiac function in ischemic heart disease and congestive heart faiulre patients with type2 diabetes
Date of disclosure of the study information 2013/04/15
Last modified on 2021/05/07 10:15:45

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Basic information

Public title

The effect by DPP-4 inhibitor for change of blood glucose, vascular endothelial function, and cardiac function in ischemic heart disease and congestive heart faiulre patients with type2 diabetes

Acronym

The effect by DPP-4 inhibitor for change of blood glucose, vascular endothelial function, and cardiac function in ischemic heart disease and congestive heart faiulre patients with type2 diabetes

Scientific Title

The effect by DPP-4 inhibitor for change of blood glucose, vascular endothelial function, and cardiac function in ischemic heart disease and congestive heart faiulre patients with type2 diabetes

Scientific Title:Acronym

The effect by DPP-4 inhibitor for change of blood glucose, vascular endothelial function, and cardiac function in ischemic heart disease and congestive heart faiulre patients with type2 diabetes

Region

Japan


Condition

Condition

ischemic heart disease and congestive heart failure

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to investigate the change of blood glucose, vascular endothelial function, cardiac function by DPP-4 inhibitor in ischemic heart diasease and congestive heart failure patients with type 2 diabetes.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

blood glucose lowering effect, vascular endothelial function, cardiac function, safety

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

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

Control) Standard Therapy

Interventions/Control_2

Intervention) DPP-4 Inhibitor

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 diabetes patients
2)20<age<80
3)Informed consent by document is obtained

Key exclusion criteria

1)diabetic ketoacidosis, diabetic coma
2) severe liver dysfunction
3)sepsis, before and after operation, severe trauma
4) pregnant person
5) patient with hypersensitivity for DPP-4 inhibitor
6)No document for informed consent
7)Inappropriate patients judged by doctor

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takafumi Inokuchi

Organization

Saitama Medical Center, Saitama Medical University

Division name

Division of Cardiology

Zip code


Address

1981 Kamoda, Kawagoe

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Saitama Medical Center, Saitama Medical University

Division name

Division of Cardiology

Zip code


Address


TEL

049-228-3400

Homepage URL


Email



Sponsor or person

Institute

Saitama Medical Center, Saitama Medical University

Institute

Department

Personal name



Funding Source

Organization

Saitama Medical Center, Saitama Medical University

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



Other administrative information

Date of disclosure of the study information

2013 Year 04 Month 15 Day


Related information

URL releasing protocol


Publication of results

Unpublished


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

Terminated

Date of protocol fixation

2013 Year 03 Month 05 Day

Date of IRB

2013 Year 03 Month 05 Day

Anticipated trial start date

2013 Year 04 Month 15 Day

Last follow-up date

2013 Year 04 Month 15 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 04 Month 13 Day

Last modified on

2021 Year 05 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012256


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name