A Prospective Observational Study of patients who switched from SGLT2 inhibitor tablets to luseogliflozin OD film formulation in terms of feeling, Efficacy and Safety of taking the medicine.

A Prospective Observational Study of patients who switched from SGLT2 inhibitor tablets to luseogliflozin OD film formulation in terms of feeling, Efficacy and Safety of taking the medicine. - A Survey of feeling of taking Lusefi OD film formulation

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000050476

Enrollment

Registered

2023-04-01

Start date

2023-04-01

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients with type 2 diabetes mellitus who have been switched from Lusefi tablets to Lusefi OD film, or from other SGLT-2 inhibitors to Lusefi OD film. (2) Patients who have consented to the purpose of this survey

Exclusion criteria

Exclusion criteria: (1) Patients who changed from Lusefi OD film to Lusefi tablets or other SGLT-2 inhibitor tablets during the study period. (2) Patients who have changed or added other hypoglycemic drugs. (3) Patients who have their medications packaged in a single package.

Design outcomes

Primary

Measure	Time frame
1) OHA-Q ver.2 after 1 month of switching 2) The change from baseline in HbA1c after 6 months of switching	—

Secondary

Measure	Time frame
1) Change over time from baseline in HbA1c up to 6 months after the switch 2) Change over time in the following items a) to d) up to 6 months after the switch a) 1.5-AG b) GA c) Liver enzymes(AST,ALT,GGT) d) Weight 3) Adherence(Pill Counting) 4) Stratified analysis of the following a) to c) a) By each SGLT2 inhibitor b) By patient background c) By medication adherence 5) OHA-Q ver.2 after 6 months of switching	—

Measure

Time frame

1) Change over time from baseline in HbA1c up to 6 months after the switch 2) Change over time in the following items a) to d) up to 6 months after the switch a) 1.5-AG b) GA c) Liver enzymes(AST,ALT,GGT) d) Weight 3) Adherence(Pill Counting) 4) Stratified analysis of the following a) to c) a) By each SGLT2 inhibitor b) By patient background c) By medication adherence 5) OHA-Q ver.2 after 6 months of switching

—

Countries

Japan

Contacts

Public ContactHiroaki Seino

Seino internal Medicine Clinic internal Medicine

info@seino-clinic.jp024-983-1024

Outcome results