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 events∙adverse 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)
Study Type
OBSERVATIONAL
Enrollment
623
Research Site
Busan, South Korea
Research Site
ChungCheong, South Korea
Research Site
Daegu, South Korea
Research Site
Daejeon, South Korea
Descriptive analysis of the percentage (%) of adverse events (AEs), serious adverse events (SAEs), unexpected adverse events∙adverse drug reactions and AEs of special interest (AESI)
* Percentage (%) of AEs, SAEs and AESI in patients who are treated with Xigduo XR * Nature, incidence and severity of AE in patients who are treated with Xigduo XR * Nature, incidence and severity of unexpected adverse drug reactions in patients who are treated with Xigduo XR
Time frame: 12 or 24 weeks
Hemoglobin A1c (HbA1c)
Change in HbA1c in % during the observation period to evaluate effectivenss
Time frame: 12 or 24 weeks
Fasting plasma glucose (FPG)
Change in FPG in mg/dL during the observation period to evaluate effectivenss
Time frame: 12 or 24 weeks
2-hr post-prandial glucose (PPG-2hr)
Change of PPG-2hr in mg/dL during the observation period to evaluate effectivenss
Time frame: 12 or 24 weeks
Blood pressure
Change in blood pressure in mmHg during the observation period to evaluate effectivenss
Time frame: 12 or 24 weeks
Abdominal circumference
Change in abdominal circumference in cm during the observation period to evaluate effectiveness
Time frame: 12 or 24 weeks
Body weight
Change in body weight in Kg during the observation period to evaluate effectiveness
Time frame: 12 or 24 weeks
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Research Site
Gyeonggi-do, South Korea
Research Site
Seoul, South Korea
Research Site
Suncheon, South Korea
Research Site
Wŏnju, South Korea
Overall investigator's assessment on the outcome of the treatment
Overall investigator's assessment on the outcome of the treatment: "Improved", "Unchanged", "Worsened", "Assessment impossible"
Time frame: 12 or 24 weeks
Number of Participants With Abnormal Laboratory Values
Laboratory measures (chemistry/hematology/ urinalysis) during the observation period to evaluate the safety and tolerability of Xigduo XR based on conducted laboratory test (Laboratory tests are not mandatory because of the non-interventional nature of this study). * Chemistry: AST, ALT, BUN, Cr, Na+, K+, Total cholesterol, TG * Hematology: Hb, Hct * Urinalylsis: Proteinurea
Time frame: 12 or 24 weeks