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

JW Pharmaceutical2,448 enrolled

Overview

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.

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

Study Type

OBSERVATIONAL

Enrollment

2,448

Conditions

Type 2 Diabetes Mellitus

Interventions

AnagliptinDRUG

Anagliptin treatment for 24weeks

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

The Catholic University of Korea, Bucheon ST. Mary's hopsital

Bucheon-si, South Korea

Outcomes

Primary Outcomes

Change of HbA1C

Time frame: after 24weeks treatment

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.