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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009981
Receipt No. R000007304
Scientific Title The effect of single administration of alpha-glucosidase inhibitors or sitagliptin on glucose metabolism and gut-derived hormones
Date of disclosure of the study information 2013/08/01
Last modified on 2013/08/06

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Basic information
Public title The effect of single administration of alpha-glucosidase inhibitors or sitagliptin on glucose metabolism and gut-derived hormones
Acronym The effect of single administration of alpha-glucosidase inhibitors or sitagliptin on glucose metabolism and gut-derived hormones
Scientific Title The effect of single administration of alpha-glucosidase inhibitors or sitagliptin on glucose metabolism and gut-derived hormones
Scientific Title:Acronym The effect of single administration of alpha-glucosidase inhibitors or sitagliptin on glucose metabolism and gut-derived hormones
Region
Japan

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

Objectives
Narrative objectives1 Clarify the effects of various oral hypoglycemic agents for glucose, insulin and gut-derived hormones.
Basic objectives2 Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The changes of plasma glucose, insulin, GLP-1, GIP, glucagon, and ghrelin after meal tolerance test.
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 No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Acarbose 100mg
Interventions/Control_2 Migritol 50mg
Interventions/Control_3 Sitaguliptin 50mg
Interventions/Control_4 Control
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 Out patient of type 2 diabetes without medication. HbA1c level is less than 9%.
Key exclusion criteria Type 1 diabetes, malignancy, infection, or severe liver or renal dysfunction.
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroaki Ueno
Organization Faculty of Medicine, University of Miyazaki
Division name Neurology, Respirology, Endocrinology and Metabolism, Department of Internal Medicine
Zip code
Address 5200, Kiyotake, Miyazaki 889-1692, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroaki Ueno
Organization Faculty of Medicine, University of Miyazaki
Division name Neurology, Respirology, Endocrinology and Metabolism, Department of Internal Medicine
Zip code
Address Neurology, Respirology, Endocrinology and Metabolism, Department of Internal Medicine
TEL +81-985-85-2965
Homepage URL
Email intron@med.miyazaki-u.ac.jp

Sponsor
Institute Neurology, Respirology, Endocrinology and Metabolism,Department of Internal Medicine, Faculty of Medicine, University of Miyazaki
Institute
Department

Funding Source
Organization Sanwa kagaku Kenkyusho Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
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 08 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
2009 Year 12 Month 25 Day
Date of IRB
Anticipated trial start date
2010 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 02 Month 06 Day
Last modified on
2013 Year 08 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007304

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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