UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009965 |
|---|---|
| Receipt number | R000011669 |
| Scientific Title | Investigation of the difference among long acting insulin products in type 1 diabetes |
| Date of disclosure of the study information | 2013/02/05 |
| Last modified on | 2013/12/26 13:00:28 |
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Basic information
Public title
Investigation of the difference among long acting insulin products in type 1 diabetes
Acronym
Becoming Stable Glycemic Control with Basal Insulin Study(Best Basal Insulin Study)
Scientific Title
Investigation of the difference among long acting insulin products in type 1 diabetes
Scientific Title:Acronym
Becoming Stable Glycemic Control with Basal Insulin Study(Best Basal Insulin Study)
Region
| Japan |
Condition
Condition
type 1 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comarison of glycemic valiability among long acting insulin products
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
satandard deviation(SD) and coefficiency of valiance (CV) in fasting blood glucose
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
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 |
Interventions/Control_1
glargine ,
cross over
Interventions/Control_2
degludec
,
cross over
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)insulin user- basal -bolus method (more than 1 year)
2) intrinsic insulin secretion completely exhasuted
3) be able to use self monitoring blood glucose
Key exclusion criteria
1)other medication to affect glucose concentarion
2) within 6 nonths after new onset AMI
3) severe hypertension , liver dysfunction, renal dysfunction
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Sakaguchi |
Organization
Kobe University,
school of medicine
Division name
Diabetes and endocrinoplogy
Zip code
Address
Chuoku, Kobe
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kobe University,
Division name
Diabetes and endocrinoplogy
Zip code
Address
TEL
Homepage URL
kzhkskgc@med.kobe-u.ac.jp
Sponsor or person
Institute
Diabetes and endcrinology, Kobe university school of medicine
Institute
Department
Personal name
Funding Source
Organization
donation
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
Kobe University Hospital (Hyogo)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 02 | Month | 05 | 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
| 2013 | Year | 02 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2013 | Year | 12 | Month | 26 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 02 | Month | 05 | Day |
Last modified on
| 2013 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011669
