Unique ID issued by UMIN | UMIN000006817 |
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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 |
Liraglutide Effect and Action in Diabetes:
Evaluation of Cardiovascular Outcome Results Trial in Japan
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Liraglutide Effect and Action in Diabetes:
Evaluation of Cardiovascular Outcome Results Trial in Japan
READ
Japan |
ACS patient with type II diabetes
Medicine in general | Cardiology | Endocrinology and Metabolism |
Others
NO
The aim of the study is to evaluate the effects and inhibitive actions of Liraglutide in type II diabetics with acute coronary syndromes
Efficacy
(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
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
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.
20 | years-old | <= |
Not applicable |
Male and Female
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.
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.
20
1st name | |
Middle name | |
Last name | Koichi Node, MD. PhD. |
Saga University
Department of Cardiovascular Medicine
5-1-1 Nabeshima, Saga
0952-34-2364
node@cc.saga-u.ac.jp
1st name | |
Middle name | |
Last name | Koichi Node, MD. PhD. |
Saga University
Department of Cardiovascular Medicine
5-1-1 Nabeshima, Saga
0952-34-2364
node@cc.saga-u.ac.jp
Department of Cardiovascular Medicine, Saga University
None
Self funding
Shinkoga hospital
NO
新古賀病院(福岡県)
2011 | Year | 12 | Month | 01 | Day |
Unpublished
Completed
2011 | Year | 03 | Month | 24 | Day |
2011 | Year | 05 | Month | 01 | Day |
2015 | Year | 07 | Month | 31 | Day |
2011 | Year | 12 | Month | 01 | Day |
2015 | Year | 12 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008061
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