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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000016754
Receipt No. R000018903
Scientific Title The inhibitory effects of the SGLT2 inhibitor for progression of diabetic nephropathy, in the patients with type 2 diabetes in Japan.
Date of disclosure of the study information 2015/04/01
Last modified on 2015/03/09

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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
Middle name
Last name Saeko Sato
Organization Saitama Medical Center, Saitama Medical University
Division name Department of Nephrology and Hypertention
Zip code
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
Middle name
Last name Saeko Sato
Organization Saitama Medical Center, Saitama Medical University
Division name Department of Nephrology and Hypertention
Zip code
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
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 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 Preinitiation
Date of protocol fixation
2014 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 01 Day
Last follow-up date
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
2015 Year 03 Month 09 Day


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

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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