Last updated on October 2018

XIGDUO Extended Release (XR) Post Marketing Surveillance

Brief description of study

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.

Detailed Study Description

  • Primary objective: Descriptive analysis of the proportion (%) of adverse events (AEs), serious adverse events (SAEs), unexpected adverse eventsadverse 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)

Clinical Study Identifier: NCT03038789

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AstraZeneca Clinical Study Information Center

Research Site
WonJu, Korea, Republic of
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