UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021968 |
|---|---|
| Receipt number | R000025323 |
| Scientific Title | A randomized crossover study between insulin glulisine and insulin aspart in patients with type 1 diabetes |
| Date of disclosure of the study information | 2016/04/18 |
| Last modified on | 2016/04/18 16:45:37 |
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Basic information
Public title
A randomized crossover study between insulin glulisine and insulin aspart in patients with type 1 diabetes
Acronym
A randomized crossover study between insulin glulisine and insulin aspart in patients with type 1 diabetes
Scientific Title
A randomized crossover study between insulin glulisine and insulin aspart in patients with type 1 diabetes
Scientific Title:Acronym
A randomized crossover study between insulin glulisine and insulin aspart in patients with type 1 diabetes
Region
| Japan |
Condition
Condition
type 1 diabetes
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
comparison of the the speed of the effect between insulin glulisine and insulin aspart
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
area under curve of blood glucose level between before meal and three hours after meal
Key secondary outcomes
peak level of blood glucose after meal,
average and standard deviation of blood glucose level,
frequency of hypoglycemia,
impression from use
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
insulin glulisine injection for six days
Interventions/Control_2
insulin aspart injection for six days
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
| 3 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
# HbA1c above 5% under 9%
# diabetes duration above 2 years
# SAP (sensor augmented insulin pump) therapy
# carb count method
Key exclusion criteria
# pregnant
# oral steroid therapy
# significant obesity
# advanced diabetes coomplication
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kawamura Tomoyuki |
Organization
Osaka City University
Division name
Pediatrics
Zip code
Address
1-5-7 Asahi machi, Abenoku,Osaka
TEL
06-6645-3816
kawam@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hotta Yuko |
Organization
Osaka City University
Division name
Pediatrics
Zip code
Address
1-5-7 Asahi machi, Abenoku,Osaka
TEL
06-6645-3816
Homepage URL
kky_hotta@yahoo.co.jp
Sponsor or person
Institute
Osaka City University
Pediatrics
Institute
Department
Personal name
Funding Source
Organization
Osaka City University
Pediatrics
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
| 2016 | Year | 04 | Month | 18 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 02 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 19 | 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
| 2016 | Year | 04 | Month | 18 | Day |
Last modified on
| 2016 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025323
