UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005331 |
|---|---|
| Receipt number | 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 09:36:16 |
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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
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
hmiyoshi@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006338
