UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042598 |
|---|---|
| Receipt number | R000048604 |
| Scientific Title | Physician and patient awareness survey on taking oral hypoglycemic agents, especially once-weekly formulations. |
| Date of disclosure of the study information | 2020/11/30 |
| Last modified on | 2021/08/03 10:52:12 |
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Basic information
Public title
Physician and patient awareness survey on taking oral hypoglycemic agents, especially once-weekly formulations.
Acronym
Physician and patient awareness survey on taking oral hypoglycemic agents, especially once-weekly formulations.
Scientific Title
Physician and patient awareness survey on taking oral hypoglycemic agents, especially once-weekly formulations.
Scientific Title:Acronym
Physician and patient awareness survey on taking oral hypoglycemic agents, especially once-weekly formulations.
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will clarify the current status of treatment with oral hypoglycemic agents for type 2 diabetes, as well as the perceptions, expectations, and needs of Physicians and patients regarding the administration of oral hypoglycemic agents.
Basic objectives2
Others
Basic objectives -Others
We will contribute to the realization of "patient-centered medical care" that respects the lifestyle, needs, values, and preferences of type 2 diabetic patients and the optimization of diabetes treatment.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Impact of Informed Choice on Physician-Patient Consciousness Gap on Weekly Oral Hypoglycemic Drugs.
Key secondary outcomes
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
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
*Physicians: Physicians who treat an average of 5 or more type 2 diabetic patients a month
*Patients: Type 2 diabetic patients aged 20 years or older who regularly visit medical institutions for the treatment of type 2 diabetes and are prescribed oral hypoglycemic drugs.
Key exclusion criteria
Patients: Patients who are already taking the once upon a week oral hypoglycemic drug.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Kazunori |
| Middle name | |
| Last name | Aruse |
Organization
QLife Co., Ltd.
Division name
CEO
Zip code
1050001
Address
4-3-9 Toranomon, Minato-ku, Tokyo
TEL
03-6860-5020
sst@qlife.co.jp
Public contact
Name of contact person
| 1st name | Yuriko |
| Middle name | |
| Last name | Kitahara |
Organization
QLife Co., Ltd.
Division name
SST
Zip code
1050001
Address
4-3-9 Toranomon, Minato-ku, Tokyo
TEL
03-6860-5020
Homepage URL
y-kitahara@qlife.co.jp
Sponsor or person
Institute
KISSEI PHARMACEUTICAL CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
KISSEI PHARMACEUTICAL CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical corporation Takahashi clinic clinical trial examination committee
Address
Medical Hat, 1st floor, 1-31, Iwayakitamachi, Nada-ku, Kobe-shi, Hyogo
Tel
03-43662-4504
no-mori@mebix.co.jp
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
| 2020 | Year | 11 | Month | 30 | Day |
Related information
URL releasing protocol
http://lifescience.co.jp/yk/yk21/ykj2107.html
Publication of results
Published
Result
URL related to results and publications
http://lifescience.co.jp/yk/yk21/ykj2107.html
Number of participants that the trial has enrolled
1006
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 07 | Month | 30 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 11 | Month | 10 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 27 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 28 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 28 | Day |
Date trial data considered complete
| 2021 | Year | 01 | Month | 13 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 18 | Day |
Other
Other related information
*We conduct a web-based questionnaire survey from Novenber 27, 2020 to December 31, 2020 for patients with Type 2 diabetes in QLife members, etc.
*We conduct a web-based questionnaire survey from Novenber 27, 2020 to December 31, 2020 for diabetic Physicians with registered in Rakuten Insight.
Management information
Registered date
| 2020 | Year | 11 | Month | 30 | Day |
Last modified on
| 2021 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048604
| 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 |
