UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011037 |
|---|---|
| Receipt number | R000012742 |
| Scientific Title | In Hiroshima, Tresiba (Insulin Degludec) Effect and Safty in Diabetes study |
| Date of disclosure of the study information | 2013/06/26 |
| Last modified on | 2017/07/03 13:46:02 |
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Basic information
Public title
In Hiroshima, Tresiba (Insulin Degludec) Effect and Safty in Diabetes study
Acronym
Hiroshima Trendy Study
Scientific Title
In Hiroshima, Tresiba (Insulin Degludec) Effect and Safty in Diabetes study
Scientific Title:Acronym
Hiroshima Trendy Study
Region
| Japan |
Condition
Condition
Diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
assesment of the achievment rate of HbA1c <6.9% of insulin Degludec (Tresiba) in daily medical practice and safty of Tresiba.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
achievment rate of HbA1c <6.9%
Key secondary outcomes
number of all adverse events, achievment rate of fasting blood glucose < 80-100 mg/dl, variation of HbA1c, variation of fasting blood glucose and blood glucose before dinner, variation of body weight, number of all low blood glucose phenomenon
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
Patients who is adapted for insulin therapy, and is suited for conditions below
1. Tresiba has never used
2. Who chan inject insulin themselves
Key exclusion criteria
1. who use insulin only short term
2. women in pregnant or during lactation
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayasu Yoneda |
Organization
Hiroshima University Hospital
Division name
Department of Endocrinology and Metabolism
Zip code
Address
1-2-3, Kasumi, Minami-ku, Hiroshima-shi, Hiroshima, 734-8551
TEL
082-257-5555
masayone17@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Kobuke |
Organization
Hiroshima University Hospital
Division name
Department of Endocrinology and Metabolism
Zip code
Address
1-2-3, Kasumi, Minami-ku, Hiroshima-shi, Hiroshima, 734-8551
TEL
082-257-5198
Homepage URL
kazu-kobuke@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University Hospital Department of Endocrinology and Metabolism
Institute
Department
Personal name
Funding Source
Organization
Hiroshima University Hospital Department of Endocrinology and Metabolism
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
広島大学病院（広島県）
安芸太田病院（広島県）
安佐市民病院（広島県）
西条中央病院（広島県）
中国労災病院（広島県）
土谷総合病院（広島県）
原田病院（広島県）
東広島医療センター（広島県）
広島西医療センター（広島県）
三原市医師会病院（広島県）
三次医療センター（広島県）
三次中央病院（広島県）
村上記念病院（広島県）
江草玄士クリニック（広島県）
大手町こぶけ内科クリニック（広島県）
天神川なかむら内科（広島県）
高山内科クリニック（広島県）
かわむら内科クリニック（広島県）
おだ内科クリニック（広島県）
河面内科医院（広島県）
野島内科医院（広島県）
片岡内科クリニック（広島県）
吉島病院（広島県）
原田病院（広島県）
NTT西日本健康管理センター（広島県）
西条市民病院（広島県）
山本整形外科病院（広島県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 06 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
J Diabetes Investig. 2016 Jan;7(1):94-9. doi: 10.1111/jdi.12373. Epub 2015 Jun 10.
Efficacy and safety of insulin degludec in Japanese patients with type？1 and type？2 diabetes: 24-week results from the observational study in routine clinical practice.
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
Main results already published
Date of protocol fixation
| 2013 | Year | 05 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 29 | Day |
Last follow-up date
| 2015 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2016 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 07 | Month | 31 | Day |
Other
Other related information
Observation point: body weight, blood glucose by SMBG, HbA1c, Total cholesterol, TG, HDL-cholesterol, any adverse event.
and Questionnaire about QOL by using DTR-QOL Questionnaire sheet and Questionnaire about insulin device.
Management information
Registered date
| 2013 | Year | 06 | Month | 25 | Day |
Last modified on
| 2017 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012742
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
