NCT04267601

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

A Non-interventional, Single Group, Open-label, Multicenter Observational Study to Evaluate the Efficacy and Safety of Anagliptin in Type 2 Diabetic Patients With Other DPP4is as Mono or Combination Therapy With Insufficient Glucose Control

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 2,448 (actual)
• Sponsor: JW Pharmaceutical · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Anagliptin	Anagliptin treatment for 24weeks

Timeline

• Start date: 2017-07-06
• Primary completion: 2021-03-30
• Completion: 2021-09-30
• First posted: 2020-02-13
• Last updated: 2021-04-29

Locations

1 site across 1 country: South Korea