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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Type 2 Diabetes Mellitus
- Sponsor
- JW Pharmaceutical
- Enrollment
- 2448
- Locations
- 1
- Primary Endpoint
- Change of HbA1C
- Last Updated
- 5 years ago
Overview
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
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Change of HbA1C
Time Frame: after 24weeks treatment