Korean Observational Study to Evaluate the Efficacy and Safety of Anagliptin Switching From Other DPP4is in type2 DM (SSUG)

JW Pharmaceutical

Status: Unknown

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Anagliptin

Study type: Observational

Funder types: Industry

Identifiers

NCT04267601

JWP-GDL-402

Details and patient eligibility

About

This study was designed as a non-interventional, single-group, open-label, multicenter observational study for patients with type 2 diabetes in the real world clinical setting.

Full description

Subjects will visit the site on the 12th week (Visit 2) and 24th week (Visit 3) from the registration date (Visit 1) to confirm the efficacy and safety.

Primary endpoint

• HbA1c change after 24 weeks treatment

Secondary endpoint

• Average rate of change in HbA1c after baseline
• Ratio of subjects with HbA1c<7% after 24 weeks
• Ratio of subjects with HbA1c<6.5% after 24 weeks
• Subgroup analysis by gender, age, BMI, medical history, renal function, liver function, conventional DPP4 inhibitors therapy, concomitant Oral Antidiabetic Drug, duration of disease

Safety endpoint : Adverse Event

Enrollment: 2,448 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 19 years of age at the time of consenting
• Understands and is willing to sign an informed consent form (ICF)
• HbA1c≥7.0%
• within 7days before registration, continuing other DPP4is alone or combined therapy for than 8 weeks

Exclusion criteria

• Prior exposure to Anagliptin