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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006855
Receipt No. R000008106
Scientific Title the efficacy for type 2 Diabetes of Repaglinide taking twice or three times a day
Date of disclosure of the study information 2011/12/15
Last modified on 2012/09/20

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Basic information
Public title the efficacy for type 2 Diabetes of Repaglinide taking twice or three times a day
Acronym Repaglinide:twice or three times a day
Scientific Title the efficacy for type 2 Diabetes of Repaglinide taking twice or three times a day
Scientific Title:Acronym Repaglinide:twice or three times a day
Region
Japan

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

Objectives
Narrative objectives1 the comparison Rapaglinide efficacy for diabetes between taking twice or three times a day
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes HbA1c,GA,1.5AG
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 repaglinide taking twice a day
Interventions/Control_2 repaglinide taking three times a day
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 patient with type 2 diabetes not using insulin , SU and glinide type drugs
Key exclusion criteria 1.type 1 diabetes
2.severe liver dysfunction
3.severe renal dysfunction
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazutaka Aoki
Organization Yokohama City University Hospital
Division name Department of Endocrinology and Metabolism
Zip code
Address 3-9 Fuku-ura, kanazawa-ku, Yokohama 236-0004
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Yokohama City University Hospital
Division name Department of Endocrinology and Metabolism
Zip code
Address 3-9 Fuku-ura, kanazawa-ku, Yokohama 236-0004
TEL 045-787-2511
Homepage URL
Email

Sponsor
Institute Graduate School of Medicine, Yokohama City University
Institute
Department

Funding Source
Organization self funding
Organization
Division
Category of Funding Organization Other
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 横浜市立大学附属病院(神奈川県)、中島内科クリニック(神奈川県)

Other administrative information
Date of disclosure of the study information
2011 Year 12 Month 15 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
2011 Year 06 Month 15 Day
Date of IRB
Anticipated trial start date
2011 Year 07 Month 15 Day
Last follow-up date
2012 Year 09 Month 14 Day
Date of closure to data entry
2012 Year 09 Month 14 Day
Date trial data considered complete
2012 Year 09 Month 14 Day
Date analysis concluded
2012 Year 10 Month 30 Day

Other
Other related information

Management information
Registered date
2011 Year 12 Month 07 Day
Last modified on
2012 Year 09 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008106

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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