Study identifier:D1691R00001
ClinicalTrials.gov identifier:NCT03038789
EudraCT identifier:N/A
CTIS identifier:N/A
XIGDUO extended release (XR) (DAPAGLIFLOZIN/METFORMIN XR FDC) Regulatory Postmarketing Surveillance To Observe Safety and effectiveness Of XigduoXR (Registered) In Korean Patients
Adult patients with type 2 diabetes mellitus
N/A
No
-
All
623
Observational
N/A
Allocation: -
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -
Verified 01 Jul 2020 by AstraZeneca
AstraZeneca
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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)
Location
Location
DaeGu, Republic of Korea
Location
Seoul, Republic of Korea
Location
ChungCheong, Republic of Korea
Location
GyeongGi, Republic of Korea
Location
Busan, Republic of Korea
Location
DaeJeon, Republic of Korea
Location
WonJu, Republic of Korea
Location
SunCheon, Republic of Korea
Arms | Assigned Interventions |
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