UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006855 |
|---|---|
| Receipt number | 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 19:50:35 |
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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
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
Sponsor or person
Institute
Graduate School of Medicine, Yokohama City University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008106
