UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000026086
Receipt number	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 17:23:52

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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

Scientific Title

Scientific Title:Acronym

Region

Japan

Condition

Type 2 diabetes mellitus

Classification by specialty

Medicine in general Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

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 or person

Institute

MSD K.K.

Institute

Department

Personal name

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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Value
https://center6.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