UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037043 |
|---|---|
| Receipt number | R000042107 |
| Scientific Title | Variable effects of diabetes-related medications on SGLT2-induced eGFR changes in diabetic patients |
| Date of disclosure of the study information | 2019/06/13 |
| Last modified on | 2022/06/30 22:51:42 |
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Basic information
Public title
Variable effects of diabetes-related medications on SGLT2-induced eGFR changes in diabetic patients
Acronym
SGLT2-induced eGFR changes in diabetic patients
Scientific Title
Variable effects of diabetes-related medications on SGLT2-induced eGFR changes in diabetic patients
Scientific Title:Acronym
SGLT2-induced eGFR changes in diabetic patients
Region
| Japan |
Condition
Condition
diabetes mellitus
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify variable effects of diabetes-related medications on SGLT2-induced eGFR changes in diabetic patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The changes in eGFR over one year in diabetic patients using combination drugs given SGLT2 inhibitors
Key secondary outcomes
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Men and women who were diagnosed with diabetes mellitus taking SGLT-2 inhibitor
Key exclusion criteria
Patients who fall under any of HbA1c> 11.0, use of steroids, use of immunosuppressant, use of NSAID, or other acute disease
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Toshihiko |
| Middle name | |
| Last name | Suzuki |
Organization
Tokyo Bay Urayasu Ichikawa Medical Center
Division name
Department of Nephrology, Endocrinology and Diabetes
Zip code
2790001
Address
3-4-32 Todaijima, Urayasu, Chiba, Japan
TEL
0473513101
toshi-s@xj9.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Koichi |
| Middle name | |
| Last name | Kitamura |
Organization
Tokyo Bay Urayasu Ichikawa Medical Center
Division name
Department of Nephrology, Endocrinology and Diabetes
Zip code
2790001
Address
3-4-32 Todaijima, Urayasu, Chiba, Japan
TEL
0473513101
Homepage URL
japan.koichi@gmail.com
Sponsor or person
Institute
Tokyo Bay Urayasu Ichikawa Medical Center
Institute
Department
Personal name
Funding Source
Organization
Tokyo Bay Urayasu Ichikawa Medical Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Bay Urayasu Ichikawa Medical Center
Address
3-4-32 Todaijima, Urayasu, Chiba, Japan
Tel
0473513101
toshi-s@xj9.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
| 2019 | Year | 06 | Month | 13 | Day |
Related information
URL releasing protocol
https://www.nature.com/articles/s41440-020-00590-1
Publication of results
Published
Result
URL related to results and publications
https://www.nature.com/articles/s41440-020-00590-1
Number of participants that the trial has enrolled
255
Results
Background treatment with metformin diminished the SGLT2i induced reductions in eGFR after 3 months of SGLT2i therapy in patients with type 2 diabetes and hypertension(-2.29 vs -5.85 mL/min/1.73m2 for metformin users (n=126) and nonusers (n=97), respectively).
Results date posted
| 2022 | Year | 06 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 12 | Month | 04 | Day |
Baseline Characteristics
N (male female) 223 (149/74)
Age (y/o) 58.1
Body weight (kg) 77.9
BMI (kg/m2) 28.4
HbA1c (%) 7.89
LDL-cholesterol (mg/dL) 108.4
eGFR (mL/min/1.73 m2) N (%)
>90 44 (19.7%)
90 > >60 120 (53.8%)
60 > >45 38 (17.0%)
45 > >30 13 (5.8%)
30 > 8 (3.6%)
Participant flow
A total of 255 patients were selected and 223 who did not meet the exclusion criteria were validated.
Adverse events
None
Outcome measures
The following items were evaluated at months 0, 3, 6, and 12
Blood pressure
Body weight
eGFR
HbA1c
Cr
LDL-C
Mg
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 31 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 02 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
patient characteristics
Age
BW
BMI
HbA1c
Systolic BP
Diastolic BP
LDL-C
Mg
eGFR
Albuminuria
medications
RAS inhibitor
Calcium channel blocker
Be-ta blocker
DPP4 inhibitor
GLP-1 inhibitor
Management information
Registered date
| 2019 | Year | 06 | Month | 12 | Day |
Last modified on
| 2022 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042107
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| Registered date | File name |
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