Type 2 Diabetes Mellitus
Conditions
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
Interventions
DRUGAnagliptin
Anagliptin treatment for 24weeks
Sponsors
JW Pharmaceutical
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of HbA1C | after 24weeks treatment |
Countries
South Korea
Outcome results
None listed