UMIN-CTR Clinical Trial

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