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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000037043
Receipt No. R000042107
Scientific Title Variable effects of diabetes-related medications on SGLT2-induced eGFR changes in diabetic patients
Date of disclosure of the study information 2019/06/13
Last modified on 2019/06/12

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Basic information
Public title Variable effects of diabetes-related medications on SGLT2-induced eGFR changes in diabetic patients
Acronym SGLT2-induced eGFR changes in diabetic patients
Scientific Title Variable effects of diabetes-related medications on SGLT2-induced eGFR changes in diabetic patients
Scientific Title:Acronym SGLT2-induced eGFR changes in diabetic patients
Region
Japan

Condition
Condition diabetes mellitus
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify variable effects of diabetes-related medications on SGLT2-induced eGFR changes in diabetic patients
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes The changes in eGFR over one year in diabetic patients using combination drugs given SGLT2 inhibitors
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
90 years-old >=
Gender Male and Female
Key inclusion criteria Men and women who were diagnosed with diabetes mellitus taking SGLT-2 inhibitor
Key exclusion criteria Patients who fall under any of HbA1c> 11.0, use of steroids, use of immunosuppressant, use of NSAID, or other acute disease
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Toshihiko
Middle name
Last name Suzuki
Organization Tokyo Bay Urayasu Ichikawa Medical Center
Division name Department of Nephrology, Endocrinology and Diabetes
Zip code 2790001
Address 3-4-32 Todaijima, Urayasu, Chiba, Japan
TEL 0473513101
Email toshi-s@xj9.so-net.ne.jp

Public contact
Name of contact person
1st name Koichi
Middle name
Last name Kitamura
Organization Tokyo Bay Urayasu Ichikawa Medical Center
Division name Department of Nephrology, Endocrinology and Diabetes
Zip code 2790001
Address 3-4-32 Todaijima, Urayasu, Chiba, Japan
TEL 0473513101
Homepage URL
Email japan.koichi@gmail.com

Sponsor
Institute Tokyo Bay Urayasu Ichikawa Medical Center
Institute
Department

Funding Source
Organization Tokyo Bay Urayasu Ichikawa Medical Center
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 Tokyo Bay Urayasu Ichikawa Medical Center
Address 3-4-32 Todaijima, Urayasu, Chiba, Japan
Tel 0473513101
Email toshi-s@xj9.so-net.ne.jp

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
2019 Year 06 Month 13 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 Enrolling by invitation
Date of protocol fixation
2019 Year 01 Month 01 Day
Date of IRB
2019 Year 05 Month 31 Day
Anticipated trial start date
2019 Year 01 Month 02 Day
Last follow-up date
2019 Year 06 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information patient characteristics
Age
BW
BMI
HbA1c
Systolic BP
Diastolic BP
LDL-C
Mg
eGFR
Albuminuria
medications
RAS inhibitor
Calcium channel blocker
Be-ta blocker
DPP4 inhibitor
GLP-1 inhibitor

Management information
Registered date
2019 Year 06 Month 12 Day
Last modified on
2019 Year 06 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042107

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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