UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000024904