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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000021619
Receipt No. R000024904
Scientific Title Effects of sodium-glucose co-transporter 2 (SGLT2) inhibitors on biomarkers in early diabetic nephropathy in Japanese with type 2 diabetes
Date of disclosure of the study information 2016/03/31
Last modified on 2020/09/28

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Basic information
Public title Effects of sodium-glucose co-transporter 2 (SGLT2) inhibitors on biomarkers in early diabetic nephropathy in Japanese with type 2 diabetes
Acronym Nephropathy markers in type 2 diabetes with sodium-glucose co-transporter 2 (SGLT2) inhibitors
Scientific Title Effects of sodium-glucose co-transporter 2 (SGLT2) inhibitors on biomarkers in early diabetic nephropathy in Japanese with type 2 diabetes
Scientific Title:Acronym Nephropathy markers in type 2 diabetes with sodium-glucose co-transporter 2 (SGLT2) inhibitors
Region
Japan

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

Objectives
Narrative objectives1 To determine the effects of SGLT2 inhibitors on biomarkers of diabetic nephropathy in Japanese patients with type 2 diabetes.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change of urinary biomarkers (albumin excretion, L-FABP,NAG, beta 2 MG, type 4 collagen) from the baseline to the endpoint (after 1, 3 and 6 months) of SGLT2 inhibitors
Key secondary outcomes Change of BMI, various metabolic disfunctions (hypertension, glucose metabolism, lipid profile, uric acid), and renal function after 1, 3 and 6 months of SGLT2 inhibitors

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
70 years-old >=
Gender Male and Female
Key inclusion criteria Patients with type 2 diabetes who fulfilled the following criteria.
1) Aged more than 20, less than 70
2) Patients whose baseline eGFR was >= 30ml/min/1.73m^2
3)Patients treated with diet, exercise or antidiabetic medications except SGLT2 inhibitor.
4) Having provided voluntary written consent for participation in this study.
Key exclusion criteria Patients corresponding to any of the following are inapplicable
1) Patients with a history of allergy to any component of the study medications
2)Patients with severe complications( liver disease, mental disorder, cancer)
3)Patients with severe ketosis or diabetic coma.
4)Patients with severe infections, perioperative status, or severe trauma
5) Patients whose baseline eGFR were <29 ml/min/1.73m^2
6) Patients with kidney disease other than diabetic nephropathy.(Specifically, patients with occult blood positive)
Patients with renal transplantations, or using drugs with nephrotoxic.
7)Pregnancy or lactation in women
8)Inadequacy of usingig this therapy
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuo Terauchi
Organization Yokohama City University Graduate School of Medicine
Division name Department of Endocrinology and Metabolism
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa
TEL 045-787-2639
Email terauchi@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiromi Konishi
Organization Yokohama City University Graduate School of Medicine
Division name Department of Endocrinology and Metabolism
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa
TEL 045-787-2639
Homepage URL
Email t146035b@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University Graduate School of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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 横浜市立大学附属病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2016 Year 03 Month 31 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 Main results already published
Date of protocol fixation
2015 Year 11 Month 16 Day
Date of IRB
2015 Year 11 Month 16 Day
Anticipated trial start date
2016 Year 02 Month 01 Day
Last follow-up date
2017 Year 10 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective observational study Recruitment of Subject:
Patients with type 2 diabetes in our hospital and Yokohama Chuo Hospital who fulfilled the inclusion/ exclusion criteria.
Recruitment period:from February 2016 to October 2017
To determine the effects of SGLT2 inhibitors on biomarkers of diabetic nephropathy in Japanese with type 2 diabetes.

Management information
Registered date
2016 Year 03 Month 25 Day
Last modified on
2020 Year 09 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024904

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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