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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000031677
Receipt No. R000036146
Scientific Title Metformin Adherence and effect of reduction of dosing frequency in type 2 diabetes
Date of disclosure of the study information 2018/03/12
Last modified on 2018/03/12

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Basic information
Public title Metformin Adherence and effect of reduction of dosing frequency in type 2 diabetes
Acronym metformin adherence study
Scientific Title Metformin Adherence and effect of reduction of dosing frequency in type 2 diabetes
Scientific Title:Acronym metformin adherence study
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 (1)to evaluate association between drug adherence and clinical parameters in metformin using type 2 diabetes
(2)to evaluate alteration of glucose associated index and drug adherence by switching metformin twice daily administration to once daily in type 2 diabetes
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes HbA1c
Key secondary outcomes change of daily glucose fluctuation measured by Flash glucose monitoring, medication adherence scale for patients with chronic disease in Japan, Medication possession ratio.

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 <study1>
Type 2 diabetes who use twice daily metformin
<study2>
Type 2 diabetes who use twice daily 500mg metformin and conventional dosage DPP4 inhibitor
Key exclusion criteria (1)the patients whose antidiabetes medication was changed within 2 month
(2)the patients who reject the study participation
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazutomi Yoshiuchi
Organization Osaka kaisei hospital
Division name department of diabetes care medicine
Zip code
Address 1-6-10, Miyahara, Yodogawa-ku, Osaka-city, Osaka
TEL 0663936234
Email yoshiuchi.k@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Saeko Osawa
Organization Osaka kaisei hospital
Division name department of diabetes care medicine
Zip code
Address 1-6-10, Miyahara, Yodogawa-ku, Osaka-city, Osaka
TEL 0663936234
Homepage URL
Email s-osawa@umin.ac.jp

Sponsor
Institute Osaka kaisei hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2018 Year 03 Month 12 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
by switching metformin to once daily administration in type 2 diabetes
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 Enrolling by invitation
Date of protocol fixation
2018 Year 03 Month 12 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information <study1>
The study is a cross sectional protocol which evaluate associations between drug adherence and glycemic control and other clinical parameters in type 2 diabetes who use twice or more daily metformin. (n=200)
<study2>
The study is prospective observational protocol which evaluate change of glycemic control and drug adherence by switching metformin twice daily administration to once daily in type 2 diabetes.(n=80)

Management information
Registered date
2018 Year 03 Month 12 Day
Last modified on
2018 Year 03 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036146

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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