UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021619 |
|---|---|
| Receipt number | R000024904 |
| Scientific Title | Effects of sodium-glucose co-transporter 2 (SGLT2) inhibitors on biomarkers in early diabetic nephropathy in Japanese with type 2 diabetes |
| Date of disclosure of the study information | 2016/03/31 |
| Last modified on | 2020/09/28 13:42:24 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
t146035b@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Graduate School of Medicine
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
Address
Tel
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024904
