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

• Conditions: Type 2 Diabetes Mellitus

• Registration Number: NCT04267601
• Lead Sponsor: JW Pharmaceutical

Brief Summary

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.

Detailed 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

Study Timeline

• Study Start: 2017-07-06
• Study First Submitted: 2020-02-11
• Study First Submitted QC: 2020-02-11
• Study First Posted: 2020-02-13
• Primary Completion: 2021-03-30
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-28
• Last Update Posted: 2021-04-29
• Study Completion: 2021-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2448

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change of HbA1C	after 24weeks treatment

Trial Locations

Locations (1)

The Catholic University of Korea, Bucheon ST. Mary's hopsital; 🇰🇷 Bucheon, Korea, Republic of