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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026086
Receipt No. R000029973
Scientific Title Factors Associating Reluctance to Initiate or Continue Oral Antihyperglycemic Agent (OAHA) Treatments in Type 2 Diabetes Mellitus Patients in Japan: Observational, Cross-sectional, Patient-Reported and Web-Based Survey
Date of disclosure of the study information 2017/02/18
Last modified on 2019/08/20

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Basic information
Public title Factors Associating Reluctance to Initiate or Continue Oral Antihyperglycemic Agent (OAHA) Treatments in Type 2 Diabetes Mellitus Patients in Japan: Observational, Cross-sectional, Patient-Reported and Web-Based Survey
Acronym Factors Associating Reluctance to Initiate or Continue Oral Antihyperglycemic Agent (OAHA) Treatments in Type 2 Diabetes Mellitus Patients in Japan: Observational, Cross-sectional, Patient-Reported and Web-Based Survey
Scientific Title Factors Associating Reluctance to Initiate or Continue Oral Antihyperglycemic Agent (OAHA) Treatments in Type 2 Diabetes Mellitus Patients in Japan: Observational, Cross-sectional, Patient-Reported and Web-Based Survey
Scientific Title:Acronym Factors Associating Reluctance to Initiate or Continue Oral Antihyperglycemic Agent (OAHA) Treatments in Type 2 Diabetes Mellitus Patients in Japan: Observational, Cross-sectional, Patient-Reported and Web-Based Survey
Region
Japan

Condition
Condition Type 2 diabetes mellitus
Classification by specialty
Medicine in general Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To describe barriers to drug treatment of T2DM among the drug naive and treated patient groups.
Basic objectives2 Others
Basic objectives -Others Barriers to drug treatment of T2DM
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Questionnaire items for barriers to T2DM treatment initiation in drug-naive T2DM group and continuation or adherence for non drug-naive T2DM group.
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

Not applicable
Gender Male and Female
Key inclusion criteria Patients age 20+
Patients who receive healthcare in Japan
Patients must self-report being either:
1.Diagnosed T2DM and have seen physician in past 6 months, recommended D&E, but not started any treatment for T2DM including OAHA,
2.Suspected T2DM patients who have seen a physician in the past 6 months and were recommended D&E due to their high blood glucose/HbA1c, but have not started any treatment for T2DM including OAHA,
3.Diagnosed T2DM patients who have seen a physician in the past 6 months are currently on OAHA monotherapy, and
4.Diagnosed T2DM patients who initiated OAHA treatment but then discontinued (patient reported basis)
Able to read and understand Japanese and provide informed consent
Key exclusion criteria Diagnosed with Type 1 Diabetes Mellitus
Pregnant
Drug-induced T2DM
(Above listed 1 & 2) told by physician already being well-controlled on their glycemic levels and currently no need to engage in D&E therapy
Target sample size 625

Research contact person
Name of lead principal investigator
1st name Takekazu
Middle name
Last name Kubo
Organization MSD K.K.
Division name Medical Affairs
Zip code 102-8667
Address 1-13-12 Kudan-kita, Chiyoda-ku, Tokyo
TEL 03-6272-1000
Email ldgproject@merck.com

Public contact
Name of contact person
1st name Takekazu
Middle name
Last name Kubo
Organization MSD K.K.
Division name Medical Affairs
Zip code 102-8667
Address 1-13-12 Kudan-kita, Chiyoda-ku, Tokyo
TEL 03-6272-1000
Homepage URL
Email ldgproject@merck.com

Sponsor
Institute MSD K.K.
Institute
Department

Funding Source
Organization MSD K.K.
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 Kitamachi Clinic
Address 1-1-3 Kitamachi Kichijoji Musashino-city Tokyo
Tel 03-6779-8166
Email shingo-namiki@j-smo.com

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
2017 Year 02 Month 18 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
2017 Year 01 Month 24 Day
Date of IRB
2016 Year 11 Month 22 Day
Anticipated trial start date
2017 Year 02 Month 18 Day
Last follow-up date
2018 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Recruitment with NHWS patient panel

Management information
Registered date
2017 Year 02 Month 10 Day
Last modified on
2019 Year 08 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029973

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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