UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001562 |
|---|---|
| Receipt number | R000001889 |
| Scientific Title | Comparison of insulin detemir and insulin glargine on glucose variability in type 1 and type 2 diabetes. |
| Date of disclosure of the study information | 2008/12/10 |
| Last modified on | 2009/01/27 17:25:44 |
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Basic information
Public title
Comparison of insulin detemir and insulin glargine on glucose variability in type 1 and type 2 diabetes.
Acronym
Comparison of insulin detemir and insulin glargine.
Scientific Title
Comparison of insulin detemir and insulin glargine on glucose variability in type 1 and type 2 diabetes.
Scientific Title:Acronym
Comparison of insulin detemir and insulin glargine.
Region
| Japan |
Condition
Condition
diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
comparison of insulin detemir and insulin glargine on glucose valiability
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
episode of hypoglycemia
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
conversion from insulin glargine to insulin detemir
Interventions/Control_2
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 1 and type 2 diabetic patients receiving intensive insulin therapy with insulin glargine.
Key exclusion criteria
patients who cannot record SMBG.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsuhito Tone |
Organization
National Hospital Organization, Okayama Medical Center
Division name
Department of Diabetes and Metabolism
Zip code
Address
1711-1, Tamasu, Okayama 701-1192, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
National Hospital Organization, Okayama Medical Center
Division name
Department of Diabetes and Metabolism
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
National Hospital Organization, Okayama Medical Center
Institute
Department
Personal name
Funding Source
Organization
Non profit foundation
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2008 | Year | 12 | Month | 10 | 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
| 2008 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 12 | Month | 10 | Day |
Last modified on
| 2009 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001889
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
