UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008003 |
|---|---|
| Receipt number | R000008876 |
| Scientific Title | GLP-1 analogue therapy on glycemic control in patients undergoing cardiac surgery |
| Date of disclosure of the study information | 2012/09/01 |
| Last modified on | 2019/03/11 20:58:20 |
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Basic information
Public title
GLP-1 analogue therapy on glycemic control in patients undergoing cardiac surgery
Acronym
GLOLIA
Scientific Title
GLP-1 analogue therapy on glycemic control in patients undergoing cardiac surgery
Scientific Title:Acronym
GLOLIA
Region
| Japan |
Condition
Condition
type2 diabetes
Classification by specialty
| Cardiology | Endocrinology and Metabolism | Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of efficacy on glycemic control of combination of insulin and GLP-1 analogue in type 2 diabetes in perioperative period of cardiac surgery.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Average of M value
level of 1,5AG 10 days after operation
Key secondary outcomes
Change in BNP
frequency of hypoglycemia
frequency of insulin scale change
frequency of M value < 10
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
addition to insulin scale therapy, administration of 0.3 mg liraglutide(day -2, -1) and administration of 0.6 mg liraglutide (day 1~10)
*day 0 = day of operation
Interventions/Control_2
Insulin scale therapy from day -2 to day10
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
type 2 diabetes patient with HbA1c level above 6.0%
patients undergoing cardiac surgery
patients treated by sulfonyl urea, glinide, DPP4 inhibitor, GLP-1 analogue
Key exclusion criteria
patients treated by insulin
patients with fasting glucose level above 250 mg/dl
patient with pregnancy
history of pancreatitis
patients with gastorial and/or intestinal disorder
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisashi Makino |
Organization
National Cerebral and Cardiovascular Center
Division name
Division of Endocrinology and Metabolism
Zip code
Address
5-7-1 Fujishirodai, Suita,Osaka, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hisashi Makino |
Organization
National Cerebral and Cardiovascular Center
Division name
Division of Endocrinology and Metabolism
Zip code
Address
5-7-1 Fujishirodai, Suita,Osaka, Japan
TEL
Homepage URL
makinoh@hsp.ncvc.go.jp
Sponsor or person
Institute
GLOLIA investigation group
Institute
Department
Personal name
Funding Source
Organization
Japan Cardiovascular Research 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
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
| 2012 | Year | 09 | 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 | 12 | Month | 25 | Day |
Date of IRB
| 2011 | Year | 11 | Month | 02 | Day |
Anticipated trial start date
| 2012 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 02 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 05 | Month | 21 | Day |
Last modified on
| 2019 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008876
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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