UMIN-CTR Clinical Trial

Basic information
Public title	Study for the effect of SGLT2 inhibitors in high risk patients of dialysis with type 2 diabetes
Acronym	The effect of SGLT2 inhibitors in patients with renal dysfunction
Scientific Title	Study for the effect of SGLT2 inhibitors in high risk patients of dialysis with type 2 diabetes
Scientific Title:Acronym	The effect of SGLT2 inhibitors in patients with renal dysfunction
Region	Japan

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

Objectives
Narrative objectives1	To assess the effects of SGLT2 inhibitors on preventing the progression of eGFR decline in patients with type 2 diabetes.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase IV

Assessment
Primary outcomes	Change in eGFR decline rate between before and after 2 years of SGLT2 inhibitors administration
Key secondary outcomes	Glycemic control Weight Blood pressure Blood and Urine test (Liver, Kidney function, lipid, UA) Characteristics of patients who well responded to SGLT2 inhibitors Comparison of eGFR decline change with that in non-SGLT2 inhibitors users who were matched background

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Continuing SGLT2 inhibitors concomitant with diet therapy for more than 2 years 2) eGFR < 60ml/min/1.73m2 at starting SGLT2 inhibitors 3) There are eGFR data for more than 2 years both before and after starting SGLT2 inhibitors
Key exclusion criteria	1) type 1 diabetes 2) severe liver dysfunction 3) pregnancy, nursing woman or possibly pregnant woman 4) severe diabetic ketosis, diabetic coma 5) severe infection, pre and post operation , severe trauma 7) uncontrolled diet therapy 8) poor adherence for medication 9) patients who thought to be inappropriate to enter this study for some reasons by physician's judgments
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Yoshio Middle name Last name Kurihara
Organization	Kurihara Naika Clinic
Division name	Internal Medicine
Zip code	004-0053
Address	7-28,3-jo 5-chome, Atsubetsu-Chuo, Atsubetsu-ku, Sapporo, Hokkaido, Japan
TEL	011-892-3522
Email	ykuri@yg7.so-net.ne.jp

Public contact
Name of contact person	1st name Yoshio Middle name Last name Kurihara
Organization	Kurihara Naika Clinic
Division name	Internal Medicine
Zip code	004-0053
Address	7-28,3-jo 5-chome, Atsubetsu-Chuo, Atsubetsu-ku, Sapporo, Hokkaido, Japan
TEL	011-892-3522
Homepage URL
Email	ykuri@yg7.so-net.ne.jp

Sponsor
Institute	Kurihara Naika Clinic
Institute
Department

Funding Source
Organization	Kurihara Naika Clinic
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	National Association of Clinical Diabetes Physicians Ethical Review Committee
Address	Nakasone 1-13-6, Oguraminami-ku, Kitakyusyu, Fukuoka
Tel	011-706-8192
Email	ykuri@yg7.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	2018 Year 12 Month 15 Day

Related information
URL releasing protocol	n/a
Publication of results	Published

Result
URL related to results and publications	https://onlinelibrary.wiley.com/doi/full/10.1111/jdi.13064
Number of participants that the trial has enrolled	75
Results	%DeGFR+2y in patients who were treated with SGLT2i was significantly increased compared with the patients not treated with SGLT2i (2.3 and -21.7%, respectively; P < 0.0001). There was no increase in serious adverse events including acute kidney injury. SGLT2i was safe, and prevented further eGFR decline in patients with type 2 diabetes and advanced renal dysfunction.
Results date posted	2021 Year 05 Month 25 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	patients with type 2 diabetes who were treated with SGLT2i, and whose eGFR was <60 mL/min/1.73 m2 and had declined >20% over 2 years before initiating SGLT2i
Participant flow	from medical records
Adverse events	none
Outcome measures	clinical effectiveness of SGLT2i on renal function by analyzing the change in eGFR at 2 years after initiating SGLT2i (%DeGFR+2y) compared with that at 2 years before its initiation (%DeGFR-2y)
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 10 Month 20 Day
Date of IRB	2018 Year 10 Month 20 Day
Anticipated trial start date	2018 Year 12 Month 20 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	retrospective cohort study to assess the effects of SGLT2 inhibitors on preventing the progression of eGFR decline (%delta eGFR2years) in patients with type 2 diabetes

Management information
Registered date	2018 Year 12 Month 14 Day
Last modified on	2021 Year 05 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040173