Study identifier:D1683R00008
ClinicalTrials.gov identifier:NCT05160974
EudraCT identifier:N/A
CTIS identifier:N/A
QTERN (SAXAGLIPTIN/DAPAGLIFLOZIN FDC) Regulatory Post-Marketing Surveillance
Type 2 Diabetes Mellitus
N/A
No
-
All
679
Observational
19 Years - n/a
Allocation: N/A
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -
Verified 01 Mar 2025 by AstraZeneca
AstraZeneca
-
This is a local, prospective, non-interventional, regulatory post-marketing surveillance study. Adult patients with type 2 diabetes mellitus who are initiating Qtern as indicated by the MFDS will be included. 600 patients are followed up 12 weeks and at least 60 patients of the 600 patients are followed up 24 weeks. Patients will be treated as part of routine practice at Korean healthcare centers by accredited physicians. In this study, patients will receive Qtern as indicated in the locally approved prescribing information.
As part of a post approval commitment, the MFDS has requested a post-marketing surveillance program to characterize safety in patients who are treated with Qtern for T2DM by physicians in the normal clinical practice setting. This study is designed to confirm assess the known safety profile or identify previously unsuspected adverse reactions and to evaluate the effectiveness of Qtern under conditions of routine daily medical practice in Korea. The primary objective of this study is : Descriptive analysis of the proportion of adverse events (AEs) and serious adverse events (SAEs) in patients who are treated with Qtern for type 2 diabetes mellitus by physicians in the normal clinical practice setting over a period of 12 and 24 weeks. The secondary objectives of this study are: To follow the changes of the 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 Qtern 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
Incheon, South Korea, Republic of Korea, 21550
Location
Jeonju, South Korea, Republic of Korea, 54807
Location
Suwon-si, South Korea, Republic of Korea, 16441
Location
Seoul, South Korea, Republic of Korea, 07694
Location
Seongnam, South Korea, Republic of Korea, 13338
Location
Gwangju, South Korea, Republic of Korea, 12759
Location
Seoul, South Korea, Republic of Korea, 08832
Location
Jinju-si, South Korea, Republic of Korea, 52683
Arms | Assigned Interventions |
---|
This information is not intended to replace the informed medical advice or medical treatments of a healthcare professional. Only a physician can determine if a specific medicine is the correct treatment for a particular patient. If you have questions regarding any information contained in this site, you must consult a suitably qualified healthcare professional. Before prescribing any AstraZeneca products, Healthcare Professionals should view their country specific information.