UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002267 |
|---|---|
| Receipt number | R000002775 |
| Scientific Title | Investigation optimal dosing of insulin detemir after switching from other basal insulin by using CGM system |
| Date of disclosure of the study information | 2009/08/01 |
| Last modified on | 2009/07/29 13:22:53 |
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Basic information
Public title
Investigation optimal dosing of insulin detemir after switching from other basal insulin by using CGM system
Acronym
Investigation optimal dosing of insulin detemir after switching from other basal insulin by using CGM system
Scientific Title
Investigation optimal dosing of insulin detemir after switching from other basal insulin by using CGM system
Scientific Title:Acronym
Investigation optimal dosing of insulin detemir after switching from other basal insulin by using CGM system
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate optimal method and dose of insulin detemir after switching from other basal insulin (NPH or insulin glargine) by using CGM system in hospitalized patient with type 1 or insulin-depleted type 2 mellitus treated by basal-bolus insulin regimen.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Variability during 24 hours (Sum of difference from average blood glucose level)
Key secondary outcomes
-Difference between maximum blood glucose level and minimum blood glucose level (average of 3 days)
-Number of hypoglycemia (BG<=50mg/dL)
-Number of hyperglycemia (BG>=300mg/dL)
-Change of HbA1c
-Change of 1.5AG
-Over all adverse events
-Circumference of waist and hip
-Change of height, weight, BMI
-Change of insulin dose (total dose, basal dose, bolus dose)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Hospitalized patient in Tokyo Women's Medical University with type 1 or insulin-depleted type 2 mellitus (fasting plasma CPR <1microg)
2.Patient who is considered to change insulin therapy because target HbA1c has not been reached and blood glucose level fluctuates wildly in current insulin therapy.
3.A consent form for participating in this study is submitted
4.Males and females of age >= 20 years
5.Patient treated by basal-bolus insulin regimen using rapid-acting insulin analogue (insulin aspart or insulin lispro) and NPH or insulin glargine over 3 months
6.HbA1c >= 8.0 %, <=11.0%
7.BMI <= 26 kg/m2
8.Patient who dose not use sulfonil-urea and pioglitazone
Key exclusion criteria
1.Pregnant, or intention of becoming pregnant.
2.Patients who are judged by investigators as inappropriate subject to participant this trail.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiko Iwamoto |
Organization
Tokyo Women's Medical University
Division name
Diabetes Center
Zip code
Address
Kawada-cho, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-8111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junnosuke Miura |
Organization
Tokyo Women's Medical University
Division name
Diabetes Center
Zip code
Address
Kawada-cho, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-8111
Homepage URL
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
| 2009 | Year | 08 | 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
Date of protocol fixation
| 2009 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Random-sampling prospective observational study
Management information
Registered date
| 2009 | Year | 07 | Month | 29 | Day |
Last modified on
| 2009 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002775
