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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000024077
Receipt No. R000027722
Scientific Title Tresiba injection in the morning or evening trial
Date of disclosure of the study information 2016/10/01
Last modified on 2016/09/16

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Basic information
Public title Tresiba injection in the morning or evening trial
Acronym TIME trial
Scientific Title Tresiba injection in the morning or evening trial
Scientific Title:Acronym 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
1st name
Middle name
Last name Seika Shimoda
Organization Kumamoto university
Division name Faculty of Life Sciences
Zip code
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
1st name
Middle name
Last name Seika Shimoda
Organization Kumamoto university
Division name Faculty of Life Sciences
Zip code
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)

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 10 Month 01 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 Terminated
Date of protocol fixation
2015 Year 07 Month 17 Day
Date of IRB
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

Other
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

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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