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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000011037
Receipt No. 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

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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
Email 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
Email kazu-kobuke@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima University Hospital Department of Endocrinology and Metabolism
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012742

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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