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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006817
Receipt No. 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

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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
Institute Department of Cardiovascular Medicine, Saga University
Institute
Department

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
URL(English) https://upload.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


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