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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000032848
Receipt No. R000035928
Scientific Title Study on indicators for predicting the therapeutic effect of SGLT2 inhibitors under actual clinical practice in T2DM patients
Date of disclosure of the study information 2018/06/03
Last modified on 2018/06/02

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Basic information
Public title Study on indicators for predicting the therapeutic effect of SGLT2 inhibitors under actual clinical practice in T2DM patients
Acronym Study on indicators for predicting therapeutic effect of SGLT2 inhibitors.
Scientific Title Study on indicators for predicting the therapeutic effect of SGLT2 inhibitors under actual clinical practice in T2DM patients
Scientific Title:Acronym Study on indicators for predicting therapeutic effect of SGLT2 inhibitors.
Region
Japan

Condition
Condition type 2 diabetes mellituds
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Explore the indictors for predicting the effect of SGLT2 inhibitors
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes Improvement of HbA1c
decrese of Body Weight
Key secondary outcomes Improvement of liver function
Improvement of fatty liver

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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Japanese T2DM patients who started SGLT2 inhibitor and received regular ambulatory treatment in Osaki Citizen Hospital Division of Endocrinology and Diabetes between May 2015 and April 2017
Key exclusion criteria 1) Anti-glutamic acid decarboxylase (GAD) antibody above normal range.
2) HBs antigen or/end HCV antibody is positive.
3)Patients who discontinue the use of SGLT2 inhibitors during the period.
4)Patients who were taking acarbose and/or herbal medicines.

Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahiro Usui
Organization Osaki Citizen Hospital
Division name Division of Metabolism and Diabetes
Zip code
Address 3-8-1 Furukawahonami,Osaki ,Miyagi
TEL 0229-23-3311
Email masausui@med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masahiro Usui
Organization Osaki Citizen Hospital
Division name Division of Metabolism and Diabetes
Zip code
Address 3-8-1 Furukawahonami,Osaki ,Miyagi
TEL 0229-23-3311
Homepage URL
Email masausui@med.tohoku.ac.jp

Sponsor
Institute Osaki Citizen 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 06 Month 03 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 No longer recruiting
Date of protocol fixation
2018 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 02 Month 09 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Divide patients into HbA1c-improved group and non-improved group and examine clinical indicators with significant difference between the groups.

Management information
Registered date
2018 Year 06 Month 02 Day
Last modified on
2018 Year 06 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035928

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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