UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016754 |
|---|---|
| Receipt number | 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 | 2020/11/14 02:11:32 |
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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 | 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
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
saeko_s@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical Center, Saitama Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018903
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| Registered date | File name |
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