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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000021968
Receipt No. 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

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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
Email 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
Email kky_hotta@yahoo.co.jp

Sponsor
Institute Osaka City University
Pediatrics
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025323

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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