Adult Patients With Type 2 Diabetes Mellitus Clinical Trial
Official title:
XIGDUO Extended Release (XR) (DAPAGLIFLOZIN/METFORMIN XR FDC) Regulatory Postmarketing Surveillance To Observe Safety and Effectiveness Of XigduoXR (Registered) In Korean Patients
This is a local, prospective, non-interventional, regulatory postmarketing surveillance study. Adult patients with type 2 diabetes mellitus who are initiating Xigduo XR as indicated by the Ministry of Food and Drug Safety (MFDS) will be included.
- Primary objective: Descriptive analysis of the proportion (%) of adverse events (AEs),
serious adverse events (SAEs), unexpected adverse eventsāadverse drug reactions and AEs
of special interest (AESI) in patients who are treated with Xigduo XR for type 2
diabetes mellitus by physicians in the normal clinical practice setting over a period of
12 or 24 weeks.
- Secondary objective: To follow the changes of values of hemoglobin A1c (HbA1c), fasting
plasma glucose (FPG), 2-hr post-prandial glucose (PPG-2hr), blood pressure, abdominal
circumference and body weight and self-reported data in this cohort of patients from
baseline to completion of the study.
To evaluate the safety and tolerability of Xigduo XR in patients with type 2 diabetes
mellitus based on conducted laboratory test (Laboratory tests are not mandatory because of
the non-interventional nature of this study)
;