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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022095
Receipt No. R000025474
Scientific Title The questionnaire survey about SGLT2 inhibitors to physicians.
Date of disclosure of the study information 2016/04/27
Last modified on 2018/10/10

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Basic information
Public title The questionnaire survey about SGLT2 inhibitors to physicians.
Acronym SGLT2 inhibitors questionnaires
Scientific Title The questionnaire survey about SGLT2 inhibitors to physicians.
Scientific Title:Acronym SGLT2 inhibitors questionnaires
Region
Japan

Condition
Condition Type 2 Diabetes Mellitus
Classification by specialty
Medicine in general Hepato-biliary-pancreatic medicine Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to survey the substance of prescriptions with SGLT2 inhibitors,
and to evaluate the efficacy and safety about SGLT2 inhibitors.
Basic objectives2 Others
Basic objectives -Others Questionnaire survey
Trial characteristics_1 Others
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Not an evaluation
Key secondary outcomes

Base
Study type Others,meta-analysis etc

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Not selected
Key exclusion criteria Not selected
Target sample size 15300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kunihiro Doi
Organization Japan Physicians Association
Division name Academic Committee
Zip code
Address 1-54 ,Todo, Uji, Kyoto, Japan, 611-0013
TEL 0774-24-1885
Email kunikei@plum.ocn.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toru Setoyama
Organization Japan Physicians Association
Division name Secretariat
Zip code
Address Sumitomo Corp. Takebashi Bldg. 1-2-2, Hitotsubashi, Chiyoda-ku, Tokyo,100-0003
TEL 03-5224-6110
Homepage URL
Email jpa@oregano.ocn.ne.jp

Sponsor
Institute Japan Physicians Association
Institute
Department

Funding Source
Organization Taisho Toyama Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor No
Name of secondary funder(s) No

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 内科医(日本)

Other administrative information
Date of disclosure of the study information
2016 Year 04 Month 27 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
We distributed questionnaires to about 24000 people, received responses from 1908 people. 1585 doctors to have a prescription experience of SGLT2 inhibitor, doctors with no prescription experience was 323.
The average administration rate of SGLT2 inhibitor was 10.9%, during the treatment of diabetes. The eGFR when administered 45-60: 49.9%, 60 to 90: 36.9%.
BMI is 23 or more 27.8% of patients as a target of administration, more than 25 was 61.8%.
The reason for prescribing the weight loss (84.7%), reduction of HbA1c (43.4%), was a decrease in blood glucose (67.1%).
Careful side effects when administered, dehydrated (84.6%), urinary tract, genital infection (75.5%), polyuria, urinary frequency (38.4%), heart, brain infarction (31.3%), skin disorders (29.6%).
Doctors when using the SGLT2 inhibitors, was careful.
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 Completed
Date of protocol fixation
2016 Year 03 Month 10 Day
Date of IRB
Anticipated trial start date
2016 Year 05 Month 01 Day
Last follow-up date
2016 Year 07 Month 31 Day
Date of closure to data entry
2016 Year 08 Month 15 Day
Date trial data considered complete
2016 Year 08 Month 31 Day
Date analysis concluded
2016 Year 09 Month 30 Day

Other
Other related information No

Management information
Registered date
2016 Year 04 Month 27 Day
Last modified on
2018 Year 10 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025474

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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