UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006908 |
|---|---|
| Receipt number | R000008165 |
| Scientific Title | The surveillance regarding the ultra-rapid insulin glulisine (Apidra) |
| Date of disclosure of the study information | 2012/03/01 |
| Last modified on | 2015/02/26 15:33:01 |
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Basic information
Public title
The surveillance regarding the ultra-rapid insulin glulisine (Apidra)
Acronym
The surveillance regarding the ultra-rapid insulin glulisine (Apidra)
Scientific Title
The surveillance regarding the ultra-rapid insulin glulisine (Apidra)
Scientific Title:Acronym
The surveillance regarding the ultra-rapid insulin glulisine (Apidra)
Region
| Japan |
Condition
Condition
Type1 Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The examination for the safety and efficacy of insulin glulisine Apidra under the CSII management.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
FPG/PPG, Hba1c, 1.5AG, the amount of Insulin, Hypoglycemia, Quality of Life(QOL)
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
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
Randomized cross-over trial divided with the usual insulin group (Group1) and the Apidra group (Group2) for totally six months. After using three months, the usual insulin in (Group1) is changed into Apidra and the Apidra in (Group2) is changed into the usual insulin to continue the treatment for more three months.
Basically the tube should be changed every three day.
Interventions/Control_2
Randomized cross-over trial divided with the usual insulin group (Group1) and the Apidra group (Group2) for totally six months. After using three months, the usual insulin in (Group1) is changed into Apidra and the Apidra in (Group2) is changed into the usual insulin to continue the treatment for more three months.
Basically the tube should be changed every three 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The current CSII patients who can agree to the examination, selected by the doctor properly.
Key exclusion criteria
1) Pregnant
2) Patient that doctor cannot screen
properly because of any reason.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoichi Imamura |
Organization
aozora clinic
Division name
Internal medicine
Zip code
Address
1068-4 Oazaharakoga, Miyaki-cho, Miyaki, Saga Prefecture.
TEL
0942-94-9811
aozoraclimamura@forest.on.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoichi Imamura |
Organization
aozora clinic
Division name
Internal medicine
Zip code
Address
1068-4 Oazaharakoga, Miyaki-cho, Miyaki, Saga Prefecture.
TEL
0942-94-9811
Homepage URL
http://asindtj.org
aozoraclimamura@forest.on.ne.jp
Sponsor or person
Institute
aozora clinic
Institute
Department
Personal name
Funding Source
Organization
Association for the study of Innovative Diabetes Treatment in
Japan (ASINDTJ)
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 03 | 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
Preinitiation
Date of protocol fixation
| 2011 | Year | 11 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 05 | 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
| 2011 | Year | 12 | Month | 19 | Day |
Last modified on
| 2015 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008165
