UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022095 |
|---|---|
| Receipt number | 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 15:52:07 |
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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
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
jpa@oregano.ocn.ne.jp
Sponsor or person
Institute
Japan Physicians Association
Institute
Department
Personal name
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
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
Value
https://center6.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 |
