UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031677
Receipt number 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 12:26:38

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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 or person

Institute

Osaka kaisei hospital

Institute

Department

Personal name



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

Value
https://center6.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