MedPath

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.

Not Applicable
Conditions
Type 2 Diabetes Mellitus
Registration Number
JPRN-UMIN000050476
Lead Sponsor
Seino internal Medicine Clinic
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
60
Inclusion Criteria

Not provided

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.

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1) OHA-Q ver.2 after 1 month of switching 2) The change from baseline in HbA1c after 6 months of switching
Secondary Outcome Measures
NameTimeMethod
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
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