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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005331
Receipt No. R000006338
Scientific Title Comparison of the effect on vascular endothelial function and systemic metabolism between Liraglutide and insulin Glargine in patients with type 2 diabetes -prospective randomized controlled trial-
Date of disclosure of the study information 2011/03/28
Last modified on 2016/03/28

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Basic information
Public title Comparison of the effect on vascular endothelial function and systemic metabolism between Liraglutide and insulin Glargine in patients with type 2 diabetes -prospective randomized controlled trial-
Acronym Study for the effects of Liraglutide on vascular endothelial function and systemic metabolism in patients with type 2 diabetes
Scientific Title Comparison of the effect on vascular endothelial function and systemic metabolism between Liraglutide and insulin Glargine in patients with type 2 diabetes -prospective randomized controlled trial-
Scientific Title:Acronym Study for the effects of Liraglutide on vascular endothelial function and systemic metabolism in patients with type 2 diabetes
Region
Japan

Condition
Condition type 2 diabetes mellitus
Classification by specialty
Medicine in general Cardiology Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the effects on arteriosclerosis between Liraglutide and insulin Glargine in patients with type 2 diabetes
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase IV

Assessment
Primary outcomes Change in FMD (Flow mediated dilatation)
Key secondary outcomes 1) glucose and lipid metabolism, 2) beta cell function, 3) changes in TBI(Toe-brachial index) and Task force monitor, 4) several biomarkers (adipokines, oxidative stress, etc)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Liraglutide
Interventions/Control_2 Insulin Glargine
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 1) patients with type 2 diabetes using glimepiride (0.5mg-2mg) and/or metformin and/or DPP-4 inhibitor, 2) HbA1c 7.4-10.5% (NGSP), 3) blood pressure and lipids are well controlled
4) written informed consent
Key exclusion criteria 1) patients who received insulin injection therapy, 2) severe hepatic dysfunction, renal dysfunction, heart failure, 3) history of angina, myocardial infarction, stroke or other arteriosclerotic diseases, 4) patients who receive more than three antihypertensive agents, 5) patients who receive more than two antidyslipidemia agents, 6) history of anaphylaxis of liragrutide or insulin glargine, 7) pregnancy, 8) patients who are inadequate to enter this study due to the other reasons by physician's judgments
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideaki Miyoshi
Organization Hokkaido University Hospital
Division name Department of Internal Medicine II
Zip code
Address Nishi 5, Kita 14, Kita-ku, Sapporo, Hokkaido, Japan
TEL 011-706-5915
Email hmiyoshi@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideaki Miyoshi
Organization Hokkaido University Hospital
Division name Department of Internal Medicine II
Zip code
Address Nishi 5, Kita 14, Kita-ku, Sapporo, Hokkaido, Japan
TEL 011-706-5915
Homepage URL
Email hmiyoshi@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University Hospital
Institute
Department

Funding Source
Organization The Waksman Foundation of Japan inc.
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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 北海道大学病院(北海道)、青木内科クリニック(北海道)、大塚眼科(北海道)、大通り内科クリニック(北海道)、小笠原クリニック札幌病院附属外来プラザ(北海道)、小野百合内科クリニック(北海道)、クラーク病院(北海道)、栗原内科(北海道)、桑園中央病院(北海道)、北海道社会保険病院(北海道)、北海道中央労災病院せき損センター(北海道)、萬田記念病院(北海道)、時計台病院(北海道)

Other administrative information
Date of disclosure of the study information
2011 Year 03 Month 28 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0135854
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 28 Day
Date of IRB
Anticipated trial start date
2011 Year 03 Month 01 Day
Last follow-up date
2013 Year 12 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 03 Month 28 Day
Last modified on
2016 Year 03 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006338

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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