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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000042598
Receipt No. 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

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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
Email 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
Email y-kitahara@qlife.co.jp

Sponsor
Institute KISSEI PHARMACEUTICAL CO., LTD.
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048604

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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