UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058142 |
|---|---|
| Receipt number | R000066454 |
| Scientific Title | Tofogliflozin-mediated Optimization of Fat metabolism, Lean mass, and EXercise capacity |
| Date of disclosure of the study information | 2025/06/11 |
| Last modified on | 2025/06/10 16:50:15 |
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Basic information
Public title
Tofogliflozin-mediated Optimization of Fat metabolism, Lean mass, and EXercise capacity
Acronym
TOFLEX
Scientific Title
Tofogliflozin-mediated Optimization of Fat metabolism, Lean mass, and EXercise capacity
Scientific Title:Acronym
TOFLEX
Region
| Japan |
Condition
Condition
Type 2 Diabetes Mellitus
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In patients with type 2 diabetes, we will examine the effects of tofogliflozin on blood levels of amino acids, particularly beta-aminoisobutyric acid (BAIBA), and evaluate its effects on cardiac function, renal function, muscle strength, and body composition. We will also explore the detailed mechanisms underlying the cardiorenal protective effects and effects on muscle and body composition of SGLT2 inhibitors.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change (amount and rate) in blood amino acid concentration from baseline at 48 weeks of administration
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Inclusion Criteria
(Patients who meet all of the following conditions at the time of informed consent will be eligible for the study.)
1. Patients with type 2 diabetes mellitus
2. Patients who are scheduled to receive tofogliflozin
3. Patients aged 18 years or older at the time of informed consent
Key exclusion criteria
Exclusion Criteria
(Patients who meet any of the following conditions at the time of informed consent will be excluded from the study.)
1. Patients with a history of hypersensitivity to any component of tofogliflozin
2. Patients with severe ketosis, diabetic coma, or precoma
3. Patients with severe infections, undergoing surgery or in the perioperative period, or with serious trauma
4. Patients who have newly initiated or changed the dosage or administration of antidiabetic medication within 12 weeks prior to informed consent
5. Patients with chronic kidney disease (CKD) stage 4 or 5
6. Pregnant or lactating women, or women who intend to become pregnant
7. Patients deemed inappropriate for inclusion in the study by the attending physician
Target sample size
33
Research contact person
Name of lead principal investigator
| 1st name | Toshiyuki |
| Middle name | |
| Last name | Yano |
Organization
Sapporo Medical University
Division name
Department of Cardiovascular, Renal and Metabolic Medicine
Zip code
060-8543
Address
South-1 West-16, Chuo-ku, Sapporo
TEL
011-611-2111
tyano@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Toshiyuki |
| Middle name | |
| Last name | Yano |
Organization
Sapporo Medical University
Division name
Department of Cardiovascular, Renal and Metabolic Medicine
Zip code
060-8543
Address
South-1 West-16, Chuo-ku, Sapporo
TEL
011-611-2111
Homepage URL
tyano@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical 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
Sapporo Medical University
Address
South-1 West-16, Chuo-ku, Sapporo
Tel
011-611-2111
tyano@sapmed.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 | 06 | Month | 11 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 05 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2025 | Year | 06 | Month | 10 | Day |
Last modified on
| 2025 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066454
