UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057387 |
|---|---|
| Receipt number | R000065546 |
| Scientific Title | Research to Explore Suitable duration for Temporary discontinuation of Sodium-GLucose coTransporter 2 Inhibitors (REST-SGLT) |
| Date of disclosure of the study information | 2025/03/24 |
| Last modified on | 2025/05/14 19:36:54 |
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Basic information
Public title
Research to Explore Suitable duration for Temporary discontinuation of Sodium-GLucose coTransporter 2 Inhibitors (REST-SGLT)
Acronym
Research to Explore Suitable duration for Temporary discontinuation of Sodium-GLucose coTransporter 2 Inhibitors (REST-SGLT)
Scientific Title
Research to Explore Suitable duration for Temporary discontinuation of Sodium-GLucose coTransporter 2 Inhibitors (REST-SGLT)
Scientific Title:Acronym
Research to Explore Suitable duration for Temporary discontinuation of Sodium-GLucose coTransporter 2 Inhibitors (REST-SGLT)
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the duration of efficacy after discontinuation of SLGT2 inhibitor in patients with type 2 diabetes mellitus treated with SLGT2 inhibitor.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The number of days until urinary glucose excretion becomes equivalent to the period without SGLT2 inhibitor administration after discontinuation of a SGLT2 inhibitor administration
Key secondary outcomes
(If two or more types of SGLT2 inhibitors were discontinued) Number of days to disappearance of urinary glucose excretion for each drug, percentage of urinary glucose disappearance within 3 days after hospitalization, urinary glucose disappearance rate, number of days until blood ketone bodies are equivalent to the period without SGLT2 inhibitor administration
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Type 2 diabetes patients who are scheduled to be admitted to the Tohoku Medical and Pharmaceutical University Hospital
2) Patients who are taking the following doses of SGLT2 inhibitor containing preparations once a day in the morning at the time of admission
Ipragliflozin 50mg/day or 100mg/day
Tofogliflozin 20mg/day
Dapagliflozin 5mg/day or 10mg/day
Canagliflozin 100mg/day
Empagliflozin 10mg/day or 25mg/day
Luseogliflozin 2.5mg/day or 5mg/day
3) Patients who plan to discontinue the above SGLT2 inhibitors after admission
4) written informed consent
Key exclusion criteria
1) Pregnancy
2) Patients who require adjustment of oral steroid dosage during our study period
3) eGFR < 45mL/min/1.73m2
4) Patients who discontinued SGLT2 inhibitors before hospitalization
5) Patients who are inadequate to enter this study due to the other reasons by physician's judgments
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yuichiro |
| Middle name | |
| Last name | Munakata |
Organization
Tohoku Medical and Pharmaceutical University
Division name
Division of Diabetes, Metabolism and Endocrinology
Zip code
983-8536
Address
1-15-1 Fukumuro Miyagino-ku, Sendai, Miyagi, Japan
TEL
022-290-8850
y.munakata@tohoku-mpu.ac.jp
Public contact
Name of contact person
| 1st name | Yuichiro |
| Middle name | |
| Last name | Munakata |
Organization
Tohoku Medical and Pharmaceutical University
Division name
Division of Diabetes, Metabolism and Endocrinology
Zip code
983-8536
Address
1-15-1 Fukumuro Miyagino-ku, Sendai, Miyagi, Japan
TEL
022-290-8850
Homepage URL
y.munakata@tohoku-mpu.ac.jp
Sponsor or person
Institute
Tohoku Medical and Pharmaceutical University
Institute
Department
Personal name
Funding Source
Organization
Kowa Company, Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee for Life Science and Medical Research, Tohoku Medical and Pharmaceutical University
Address
1-12-1 Fukumuro Miyagino-ku, Sendai, Miyagi, Japan
Tel
022-259-1221
research@hosp.tohoku-mpu.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 03 | Month | 24 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 03 | Month | 03 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 03 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
After obtaining written consent from subjects who are to be hospitalized and discontinue SGLT2 inhibitors, urine samples will be collected for 7 days from the day of hospitalization. Then, the number of days until urinary glucose excretion is equivalent to the period without SGLT2 inhibitor administration, urinary glucose disappearance rate on the third day after hospitalization, urinary glucose disappearance rate, and (when two or more types of SGLT2 inhibitors are discontinued) number of days to disappearance of urinary glucose excretion for each drug. In addition, routine blood sampling will be performed until the eighth day of hospitalization to evaluate various parameters.
Management information
Registered date
| 2025 | Year | 03 | Month | 24 | Day |
Last modified on
| 2025 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065546
