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Tofogliflozin-mediated Optimization of Fat metabolism, Lean mass, and EXercise capacity

Tofogliflozin-mediated Optimization of Fat metabolism, Lean mass, and EXercise capacity - TOFLEX

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000058142
Enrollment
33
Registered
2025-06-11
Start date
2025-07-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Interventions

None listed

Sponsors

Sapporo Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Change (amount and rate) in blood amino acid concentration from baseline at 48 weeks of administration

Countries

Japan

Contacts

Public ContactToshiyuki Yano

Sapporo Medical University Department of Cardiovascular, Renal and Metabolic Medicine

tyano@sapmed.ac.jp011-611-2111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026