UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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-
Title of the study (Brief title)	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	Rimei NIshimura
Organization	The Jikei University School of Medicine
Division name	Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine
Address	3-25-8 Nishishinbashi, Minato-ku, Tokyo,Japan
TEL	+81334331111
Email	rimei@jikei.ac.jp

Public contact
Name of contact person	Rimei NIshimura
Organization	The Jikei University School of Medicine
Division name	Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 10 Month 12 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
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.
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/icdr_e/ctr_view.cgi?recptno=R000016126