NCT04267601UnknownNot Applicable
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
JW Pharmaceutical1 site in 1 country2,448 target enrollmentStarted: July 6, 2017Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 2,448
- Locations
- 1
- Primary Endpoint
- Change of HbA1C
Study 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
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Change of HbA1C
Time Frame: after 24weeks treatment
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Not Applicable
Non-interventional Study to Assess Adherence to Treatment for Patients With RMS (MAIN-MS)Relapsing Multiple Sclerosis (RMS)NCT02921035Merck KGaA, Darmstadt, Germany594
Not yet recruiting
Not Applicable
Treatment Patterns of Neratinib in HER2+ EBC in ChinaBreast CancerNCT05491057Pierre Fabre Medicament500
Completed
Not Applicable
MultIceNtre Non-intERVentional Study for Efficacy,Safety Evaluation of BREZTRI in Pts With COPD in RussiAChronic Obstructive Pulmonary DiseaseNCT06422676AstraZeneca200
Recruiting
Not Applicable
Kesimpta (Ofatumumab) in Greek Multiple Sclerosis Patients - an Observational StudyRelapsing Multiple Sclerosis (RMS)NCT06486779Novartis Pharmaceuticals160
Completed
Phase 3
Observational Study to Investigate the Effects of Training on the Administration of Cardioplexol™Coronary Artery Bypass SurgeryValve SurgeryNCT03823521Swiss Cardio Technologies AG171