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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013817
Receipt No. R000016126
Scientific Title Jikei-Evaluation of basal insulin analogue on (nocturnal) glycemic variability with continuous glucose monitoring -existing basal insulin analogue versus Tresiba ; insulin degludec - a new basal insulin analogue, in basal-bolus treatment in type 1 diabetes-
Date of disclosure of the study information 2014/04/26
Last modified on 2016/10/26

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Basic information
Public title Jikei-Evaluation of basal insulin analogue on (nocturnal) glycemic variability with continuous glucose monitoring
-existing basal insulin analogue versus Tresiba ; insulin degludec - a new basal insulin analogue, in basal-bolus treatment in type 1 diabetes-
Acronym JET-1
Scientific Title Jikei-Evaluation of basal insulin analogue on (nocturnal) glycemic variability with continuous glucose monitoring
-existing basal insulin analogue versus Tresiba ; insulin degludec - a new basal insulin analogue, in basal-bolus treatment in type 1 diabetes-
Scientific Title:Acronym JET-1
Region
Japan

Condition
Condition Type 1 diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We compare glucose control of Degludec to ohter long-acting basal insulin analogue in Japanese patient with type 1 diabetes
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Continuous glucose value of 24 hours by CGM
Key secondary outcomes

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 degludec
Interventions/Control_2 long-acting insulin analogue other than 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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Type 1 diabetes receiving Basal-bolus insulin therapy.
Key exclusion criteria Type 2 diabetes.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Rimei NIshimura
Organization The Jikei University School of Medicine
Division name Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine
Zip code
Address 3-25-8 Nishishinbashi, Minato-ku, Tokyo,Japan
TEL +81334331111
Email rimei@jikei.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Rimei NIshimura
Organization The Jikei University School of Medicine
Division name Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine
Zip code
Address 3-25-8 Nishishinbashi, Minato-ku, Tokyo,Japan
TEL +81334331111
Homepage URL
Email rimei@jikei.ac.jp

Sponsor
Institute The Jikei University School of Medicine Japan Diabetes Foundation
Institute
Department

Funding Source
Organization Japan Diabetes Foundation
Organization
Division
Category of Funding Organization Non profit foundation
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
2014 Year 04 Month 26 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Comparison of glycemic variability in Japanese patients with type 1 diabetes receiving insulin degludec versus insulin glargine using continuous glucose monitoring: A randomized, cross-over, pilot study.

Onda Y, Nishimura R, Ando K, Takahashi H, Tsujino D, Utsunomiya K.

Diabetes Res Clin Pract. 2016 Oct;120:149-55. doi: 10.1016/j.diabres.2016.07.019.
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 Completed
Date of protocol fixation
2013 Year 10 Month 12 Day
Date of IRB
Anticipated trial start date
2014 Year 04 Month 26 Day
Last follow-up date
2015 Year 06 Month 01 Day
Date of closure to data entry
2015 Year 07 Month 01 Day
Date trial data considered complete
2015 Year 07 Month 01 Day
Date analysis concluded
2015 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2014 Year 04 Month 26 Day
Last modified on
2016 Year 10 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016126

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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