UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A randomized crossover study between insulin glulisine and insulin aspart in patients with type 1 diabetes
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Kawamura Tomoyuki
Organization	Osaka City University
Division name	Pediatrics
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	Hotta Yuko
Organization	Osaka City University
Division name	Pediatrics
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 02 Month 08 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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