UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024077 |
|---|---|
| Receipt number | 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 09:54:41 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
sshimoda@gpo.kumamoto-u.ac.jp
Sponsor or person
Institute
Kumamoto university
Institute
Department
Personal name
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
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
Value
https://center6.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 |
