UMIN-CTR Clinical Trial

Basic information
Public title	The inhibitory effects of the SGLT2 inhibitor for progression of diabetic nephropathy, in the patients with type 2 diabetes in Japan.
Acronym	The inhibitory effects of the SGLT2 inhibitor for progression of diabetic nephropathy.
Scientific Title	The inhibitory effects of the SGLT2 inhibitor for progression of diabetic nephropathy, in the patients with type 2 diabetes in Japan.
Scientific Title:Acronym	The inhibitory effects of the SGLT2 inhibitor for progression of diabetic nephropathy.
Region	Japan

Condition
Condition	diabetic nephropathy in type 2 diabetes mellitus
Classification by specialty	Medicine in general Endocrinology and Metabolism Nephrology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the inhibitory effects with SGLT2 inhibitor for progression of nephropathy in type2 diabetic patients
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	1)blood glucose lowering effect; fasting blood glucose, HbA1c, 1.5-AG, HOMA-beta, HOMA-R 2)renal function; eGFRcrest, eGFRcys, UACR 3)renal tubular function; u-Na, u-K, u-Cl, u-Mg, u-Ca, u-P, u-Zn, u-UA, u-HCO3, u-pH, FENa, FEK, FECl, FEMg, FECa, FEP, FEZn, FEUA, NAG, u-beta2MG, u-L-FABP, u-Col4
Key secondary outcomes	1)oxidant stress; hs-CRP, MDA-LDL, u-isoprostane, u-MCP-1 2)bone metabolic markers; FGF-23, whole PTH 3)lipid profile; LDL-C, HDL-C, TG 4)body fluid volume; NT-proBNP, renin, aldosterone 5)urine volume, urinary pH 6)bood pressure, heart rate, body weight, octopolar bioimpedance 7)RBC, Hb, Erythropoietin

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	oral administration of ipragliflozin (50mg/day)
Interventions/Control_2	oral administration of ipragliflozin (50mg/day)
Interventions/Control_3	oral administration of glimepiride (1-2mg/day)
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	1)Diet and exercise therapy only for one month or more, or in addition to diet and exercise therapy, in SGLT2 inhibitors other than oral hypoglycemic agents for one month or more, the glycemic control is insufficient (HbA1c 6.0% or more (NGSP)) 2)Patients who is obtained the consent in writing
Key exclusion criteria	1)Patient with a severe ketotic diabetic coma or precoma. 2)Patient with severe infectious disease, before and after operation, and a serious injury. 3)End-stage renal failure patients with severe renal impairment (eGFR <30mL / min) or during dialysis 4)A pregnant woman or woman who may be pregnant. 5)Patient with a past history of hypersensitivity for Ipragliflozin. 6)Patients who isn't obtained the consent in writing 7)Patient who is considered to be inappropriate by the chief physician.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Saeko Middle name Last name Sato
Organization	Saitama Medical Center, Saitama Medical University
Division name	Department of Nephrology and Hypertension
Zip code	350-8550
Address	1981kamoda, Kawagoe-shi, Saitama 350-8550, Japan
TEL	049-228-3400
Email	saeko_s@saitama-med.ac.jp

Public contact
Name of contact person	1st name Saeko Middle name Last name Sato
Organization	Saitama Medical Center, Saitama Medical University
Division name	Department of Nephrology and Hypertention
Zip code	350-8550
Address	1981kamoda, Kawagoe-shi, Saitama 350-8550, Japan
TEL	049-228-3400
Homepage URL
Email	saeko_s@saitama-med.ac.jp

Sponsor
Institute	Saitama Medical Center, Saitama Medical University
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	IRB of Saitama Medical Center
Address	1981 Kamoda, Kawagoe City, Saitama 350-8550, Japan
Tel	049-228-3902
Email	smcrinri@saitama-med.ac.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	埼玉医科大学総合医療センター

Other administrative information
Date of disclosure of the study information	2015 Year 04 Month 01 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	2014 Year 10 Month 01 Day
Date of IRB	2014 Year 10 Month 03 Day
Anticipated trial start date	2015 Year 04 Month 01 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 03 Month 09 Day
Last modified on	2020 Year 11 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018903