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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001202
Receipt No. R000001466
Scientific Title Comparison of Miglitol and Acarbose in Japanese patient with type 2 diabetes by using continuous glucose monitoring (CGM)
Date of disclosure of the study information 2008/06/19
Last modified on 2009/06/19

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Basic information
Public title Comparison of Miglitol and Acarbose in Japanese patient with type 2 diabetes by using continuous glucose monitoring (CGM)
Acronym MAJOR study
Scientific Title Comparison of Miglitol and Acarbose in Japanese patient with type 2 diabetes by using continuous glucose monitoring (CGM)
Scientific Title:Acronym MAJOR study
Region
Japan

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

Objectives
Narrative objectives1 We compare postprandial glucose control of Miglitol to Acarbose in Japanese patient with type 2 diabetes.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The outcome of postprandial glucose control by CGM
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration Institution is considered as a block.
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Miglitol
Interventions/Control_2 Acarbose
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. 6.0%<HbA1c<8.0%.
Key exclusion criteria Type 1 diabetes. Patients receiving insulin therapy. Severe liver dysfunction. Severe renal dysfunction.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Daisuke Tsujino
Organization The Jikei University School of Medicine
Division name Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine
Zip code
Address 3-19-18, Nishishinbashi, Minato-ku, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization The Jikei University School of Medicine
Division name Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine
Zip code
Address
TEL
Homepage URL
Email ms97-tsujino@jikei.ac.jp

Sponsor
Institute The Jikei University School of Medicine
Institute
Department

Funding Source
Organization The Jikei University School of Medicine, Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine
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
2008 Year 06 Month 19 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
2007 Year 11 Month 27 Day
Date of IRB
Anticipated trial start date
2008 Year 04 Month 01 Day
Last follow-up date
2008 Year 12 Month 01 Day
Date of closure to data entry
2008 Year 12 Month 01 Day
Date trial data considered complete
2008 Year 12 Month 01 Day
Date analysis concluded
2009 Year 04 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 06 Month 19 Day
Last modified on
2009 Year 06 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001466

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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