UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013604 |
|---|---|
| Receipt number | R000015891 |
| Scientific Title | The crossover study using insulin degludec in basal-bouls insulin therapy of childhood type 1 diabetes |
| Date of disclosure of the study information | 2014/04/02 |
| Last modified on | 2014/04/02 07:14:39 |
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Basic information
Public title
The crossover study using insulin degludec in basal-bouls insulin therapy of childhood type 1 diabetes
Acronym
JT1DDG
Scientific Title
The crossover study using insulin degludec in basal-bouls insulin therapy of childhood type 1 diabetes
Scientific Title:Acronym
JT1DDG
Region
| Japan |
Condition
Condition
type 1 diabetes
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of insulin degludec in the basal bolus insulin insulin therapy of childhood type 1 diabetic patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of HbA1c level
Key secondary outcomes
Record of self glucose monitoring
Frequency of sever hypoglycemia
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The long-acting insulin will be switched to insulin degludec. 12wk later, the basal insulin will be returned to the former insulin.
Interventions/Control_2
The subjects use the same long acting insulin. 12wk later, the long-acting insulin will be switched to insulin degludec.
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
| 0 | years-old | < |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Type 1 diabetes with Basal-Bolus therapy
more than 1 year,
using insulin glargine or insulin detemir as the basal insulin,
and using rapid acting insulin as bolus insulin.
2)at least 3 times per day of (self-monitoring of blood glucose
3) Regular visiting to clinic
5)HbA1c < 10%
Key exclusion criteria
1)patients with sever diabetes complication. (Proliferating retinopathy or renal dysfunction: serum Cre > 2.0 mg/dl).
4)judged as ineligible by clinical investigators
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoyuki Kawamura |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Pediatrics
Zip code
Address
1-5-7, Asahi-machi, Abeno-ku, Osaka, Japan
TEL
06-6645-3816
kawam@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoyuki Kawamura |
Organization
Osaka City Graduate School of Medicine
Division name
Department of Pediatrics
Zip code
Address
1-5-7, Asahi-machi, Abeno-ku, Osaka, Japan
TEL
06-6645-3816
Homepage URL
kawam@med.osaka-cu.ac.jp
Sponsor or person
Institute
Department of Pediatrics, Osaka City Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Pediatrics, Osaka City Graduate School of Medicine
Organization
Division
Category of Funding Organization
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
| 2014 | Year | 04 | Month | 02 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 04 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 02 | 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
| 2014 | Year | 04 | Month | 02 | Day |
Last modified on
| 2014 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015891
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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