UMIN-CTR Clinical Trial

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
Last 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
Email

Public contact
1st 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
Email	makinoh@hsp.ncvc.go.jp

Sponsor
Institute	GLOLIA investigation group
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008876