UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006817
Receipt number R000008061
Scientific Title Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results Trial in Japan
Date of disclosure of the study information 2011/12/01
Last modified on 2015/12/01 14:31:50

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Basic information

Public title

Liraglutide Effect and Action in Diabetes:
Evaluation of Cardiovascular Outcome Results Trial in Japan

Acronym

READ

Scientific Title

Liraglutide Effect and Action in Diabetes:
Evaluation of Cardiovascular Outcome Results Trial in Japan

Scientific Title:Acronym

READ

Region

Japan


Condition

Condition

ACS patient with type II diabetes

Classification by specialty

Medicine in general Cardiology Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of the study is to evaluate the effects and inhibitive actions of Liraglutide in type II diabetics with acute coronary syndromes

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

(1)Biomarker of cardiovascular disease (NT-proBNP,high sensitive troponin T,hs-CRP,MCP-1,eGFR,cystatinC,(S)-RAGE,MDA-LDL,AIM,etc) and shift of UACR
(2)Changes in left ventricular function (left ventricular ejection rate, left ventricular volume, diastolic function)(3)change in HbA1c,FBS
(4)safeness

Key secondary outcomes



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

Liraglutide will be administrated to the patients with type 2 diabetes within 14 days of onset of ACS. It will be continued for 6 months.

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

For entry into the study, participants must meet all of the following criteria.
(1) Aged 20 and over (Gender: regardless)
(2) type II diabetes
(3)Patients who are hospitalized for ACS such as cardiac infarction, unstable angina. (within 14days of onset)
(4)Patient with full understanding of this study and agrees with written consent. The agreement must be based on the patients' free will.

Key exclusion criteria

Exclusion criteria:patients will be excluded from the study when they meet to any of the criteria.
(1)patients with cardiogenic shock
(2)patient with serious liver disease((AST)GOT/(ALT)GPT>100)
(3)patient with serious kidney trouble.(Cre>5mg/dl and patients under dialysis)
(4)Patients with a past history of drug allergy and hypersensitivity.
(5)Pregnant and/or breast-feeding at present,or a woman of child-bearing potential.
(6)Patients with malignant neoplasms
(7)Iinsulin-requiring diabetics.(Type 1,or type 2 with depletion of insulin secretion capacity.)
(8)patients who was diagnosed that his/her condition is not appropriate to join this study.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Koichi Node, MD. PhD.

Organization

Saga University

Division name

Department of Cardiovascular Medicine

Zip code


Address

5-1-1 Nabeshima, Saga

TEL

0952-34-2364

Email

node@cc.saga-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Koichi Node, MD. PhD.

Organization

Saga University

Division name

Department of Cardiovascular Medicine

Zip code


Address

5-1-1 Nabeshima, Saga

TEL

0952-34-2364

Homepage URL


Email

node@cc.saga-u.ac.jp


Sponsor or person

Institute

Department of Cardiovascular Medicine, Saga University

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Shinkoga hospital

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

新古賀病院(福岡県)


Other administrative information

Date of disclosure of the study information

2011 Year 12 Month 01 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

Completed

Date of protocol fixation

2011 Year 03 Month 24 Day

Date of IRB


Anticipated trial start date

2011 Year 05 Month 01 Day

Last follow-up date

2015 Year 07 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2011 Year 12 Month 01 Day

Last modified on

2015 Year 12 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008061


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name