UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060509 |
|---|---|
| Receipt number | R000069222 |
| Scientific Title | Role of background metformin therapy in cardiorenal outcomes in type 2 diabetic patients treated with SGLT2 inhibitors |
| Date of disclosure of the study information | 2026/02/01 |
| Last modified on | 2026/01/29 12:05:54 |
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Basic information
Public title
Role of background metformin therapy in cardiorenal outcomes in type 2 diabetic patients treated with SGLT2 inhibitors
Acronym
Role of background metformin therapy in cardiorenal outcomes in type 2 diabetic patients treated with SGLT2 inhibitors
Scientific Title
Role of background metformin therapy in cardiorenal outcomes in type 2 diabetic patients treated with SGLT2 inhibitors
Scientific Title:Acronym
Role of background metformin therapy in cardiorenal outcomes in type 2 diabetic patients treated with 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 clarify whether background antidiabetic therapy, especially Metformin, modifies the cardiovascular and renal protective effects of SGLT2 inhibitors
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Is there any differences in the occurence of major adverse cardiovascular events (MACE), defined as acute myocardial infarction, stroke, or cardiovascular death, according to background antidiabetic therapy
Key secondary outcomes
Are there any differences in the occurence of MACE, hospitalization for heart failure and renal events (>=30% decline in estimated glomerular filtration rate or end-stage kidney disease), according to background antidiabetic therapy. We also evaluated the association of Fibrosis index 4 and those events.
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
The patients with T2DM (age >=18 y/o) who visited our outpatient clinic between April 2014 and September 2018 and were newly given SGLT2 inhibitors
Key exclusion criteria
Patients on steroid therapy or immunosuppressive agents and those with multiple missing data
Target sample size
220
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 city, Chiba
TEL
047-351-3101
toshi-s@xj9.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Takano |
Organization
Tokyo Bay Urayasu Ichikawa Medical Center
Division name
Department of Nephrology, Endocrinology and Diabetes
Zip code
2790001
Address
3-4-32, Todaijima, Urayasu city, Chiba
TEL
047-351-3101
Homepage URL
kt900928@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 city, Chiba
Tel
047-351-3101
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
| 2026 | Year | 02 | 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
227
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
Completed
Date of protocol fixation
| 2025 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 23 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patient characteristics
Age
Sex
Renal function
Metformin
Major adverse cardiovascular
Renal dysfunction events
Management information
Registered date
| 2026 | Year | 01 | Month | 29 | Day |
Last modified on
| 2026 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069222
