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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000002267
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Tokyo Women's Medical University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002775

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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