UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Tresiba injection in the morning or evening trial
Title of the study (Brief title)	TIME trial
Region	Japan

Condition
Condition	Type 2 diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess efficacy and safety of insulin degludec as a part of basal-bolus therapy for Japanese patients with type 2 diabetes.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	blood glucose profile
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
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	injection of insulin degludec in the morning
Interventions/Control_2	injection of insulin degludec in the evening
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 2 diabetes
Key exclusion criteria	The exclusion criteria were pregnant or nursing women and subjects in whom the physician deemed IDeg treatment inappropriate.
Target sample size	100

Research contact person
Name of lead principal investigator	Seika Shimoda
Organization	Kumamoto university
Division name	Faculty of Life Sciences
Address	1-1-1 Honjo Chuo-Ku, Kumamoto 860-8556, Japan
TEL	096-373-5169
Email	sshimoda@gpo.kumamoto-u.ac.jp

Public contact
Name of contact person	Seika Shimoda
Organization	Kumamoto university
Division name	Faculty of Life Sciences
Address	1-1-1 Honjo Chuo-Ku, Kumamoto 860-8556, Japan
TEL	096-373-5169
Homepage URL
Email	sshimoda@gpo.kumamoto-u.ac.jp

Sponsor
Institute	Kumamoto university
Institute
Department

Funding Source
Organization	None
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 10 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 07 Month 17 Day
Anticipated trial start date	2015 Year 08 Month 01 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 09 Month 16 Day
Last modified on	2016 Year 09 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027722