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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000010067
Receipt No. R000011694
Scientific Title GLP-1 administration test for assessing the glucose metabolism and predictive efficacy of the incretin based treatment
Date of disclosure of the study information 2013/04/01
Last modified on 2017/08/03

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Basic information
Public title GLP-1 administration test for assessing the glucose metabolism and predictive efficacy of the incretin based treatment
Acronym GLP-1 administration test
Scientific Title GLP-1 administration test for assessing the glucose metabolism and predictive efficacy of the incretin based treatment
Scientific Title:Acronym GLP-1 administration test
Region
Japan

Condition
Condition Type 2 diabetes mellitus
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purposes of this clinical trial are to assess the GLP-1 administration test reflects the insulin secretion capacity and predicts the efficacy of incretin based treatment.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1. Insulin secretion in GLP-1 administration compared to saline administration using meal tolerance test.
2. The relationship between the result of GLP-1 administration test and the changes of HbA1c after incretin based treatment.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 GLP-1
Interventions/Control_2 saline
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
75 years-old >=
Gender Male and Female
Key inclusion criteria Diabetes mellitu type 2 without using incretin based drugs.
Key exclusion criteria Patient with severe complication (proliferative retinopathy, serum cleatinine > 2.0 mg/dL, cerebrovascular disease, and/or ischemic heart diseases), severe liver dysfunction and/or dementia.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masamitsu Nakazato
Organization Miyazaki university, fuculty of medicine
Division name Neurology, Respirology, Endocrinology and Metabolism, Department of Internal Medicine
Zip code
Address 5200 Kihara, Kiyotake, Miyazaki, Miyazaki, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroaki Ueno
Organization Miyazaki university, fuculty of medicine
Division name Neurology, Respirology, Endocrinology and Metabolism, Department of Internal Medicine
Zip code
Address
TEL
Homepage URL
Email intron@med.miyazaki-u.ac.jp

Sponsor
Institute Miyazaki university
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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
2013 Year 04 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 Terminated
Date of protocol fixation
2012 Year 10 Month 12 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 01 Day
Last follow-up date
2017 Year 08 Month 03 Day
Date of closure to data entry
Date trial data considered complete
2017 Year 08 Month 03 Day
Date analysis concluded
2017 Year 08 Month 03 Day

Other
Other related information

Management information
Registered date
2013 Year 02 Month 18 Day
Last modified on
2017 Year 08 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011694

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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