UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035263 |
|---|---|
| Receipt number | R000040173 |
| Scientific Title | Study for the effect of SGLT2 inhibitors in high risk patients of dialysis with type 2 diabetes |
| Date of disclosure of the study information | 2018/12/15 |
| Last modified on | 2021/05/25 22:00:39 |
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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
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
ykuri@yg7.so-net.ne.jp
Sponsor or person
Institute
Kurihara Naika Clinic
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040173
