QTERN (SAXAGLIPTIN/DAPAGLIFLOZIN FDC) Regulatory Post-Marketing Surveillance
Launched by ASTRAZENECA · Dec 15, 2021
Trial Information
Current as of June 10, 2025
Completed
Keywords
ClinConnect Summary
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 patie...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Patients aged 19 years and older
- • 2. Patients with T2DM eligible for treatment with Qtern as indicated in the locally approved prescribing information
- • 3. Patients with evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
- Exclusion Criteria:
- • 1. Patients treated with Qtern outside of the locally approved Prescription Information in Korea
- • 2. Patients with contraindications for the use of Qtern (as described in the Korean Prescription Information)
About Astrazeneca
AstraZeneca is a global biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative medicines across various therapeutic areas, including oncology, cardiovascular, respiratory, and autoimmune diseases. With a strong commitment to scientific research and patient-centric solutions, AstraZeneca leverages cutting-edge technology and a robust pipeline to address unmet medical needs. The company collaborates with healthcare professionals, academic institutions, and other organizations to advance clinical trials and deliver transformative therapies, aiming to improve health outcomes and enhance the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Seoul, , Korea, Republic Of
Bucheon Si, , Korea, Republic Of
Changwon Si, South Korea, Korea, Republic Of
Chuncheon Si, South Korea, Korea, Republic Of
Gimcheon Si, South Korea, Korea, Republic Of
Gwangyang, South Korea, Korea, Republic Of
Iksan Si, South Korea, Korea, Republic Of
Jeju Do, South Korea, Korea, Republic Of
Jeonju Si, South Korea, Korea, Republic Of
Jindo Gun, South Korea, Korea, Republic Of
Naju Si, South Korea, Korea, Republic Of
Pyeongtaek Si, South Korea, Korea, Republic Of
Seosan Si, South Korea, Korea, Republic Of
Yeongcheon Si, South Korea, Korea, Republic Of
Ansan Si, , Korea, Republic Of
Busan, , Korea, Republic Of
Busan, , Korea, Republic Of
Changwon, , Korea, Republic Of
Cheongju Si, , Korea, Republic Of
Cheongju, , Korea, Republic Of
Daegu, , Korea, Republic Of
Daejeon, , Korea, Republic Of
Daejeon, , Korea, Republic Of
Goyang Si, , Korea, Republic Of
Gwangju, , Korea, Republic Of
Gwangmyeong, , Korea, Republic Of
Gyeonggi Do, , Korea, Republic Of
Incheon, , Korea, Republic Of
Incheon, , Korea, Republic Of
Jeonju, , Korea, Republic Of
Jinju Si, , Korea, Republic Of
Seongnam, , Korea, Republic Of
Seoul, , Korea, Republic Of
Suwon Si, , Korea, Republic Of
Uijeongbu Si, , Korea, Republic Of
Ulsan, , Korea, Republic Of
Yangsan, , Korea, Republic Of
Yongin Si, , Korea, Republic Of
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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