QTERN (SAXAGLIPTIN/DAPAGLIFLOZIN FDC) Regulatory Post-Marketing Surveillance
NCT ID: NCT05160974
Last Updated: 2025-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
679 participants
OBSERVATIONAL
2021-12-30
2024-04-01
Brief Summary
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Detailed Description
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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)
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
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
2. Patients with contraindications for the use of Qtern (as described in the Korean Prescription Information)
19 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Changwon-si, South Korea, South Korea
Research Site
Gimcheon, South Korea, South Korea
Research Site
Jeju-do, South Korea, South Korea
Research Site
Jeonju, South Korea, South Korea
Research Site
Pyeongtaek-si, South Korea, South Korea
Research Site
Seosan City, South Korea, South Korea
Research Site
Yeongcheon-si, South Korea, South Korea
Research Site
Busan, , South Korea
Research Site
Busan, , South Korea
Research Site
Busan, , South Korea
Research Site
Changwon, , South Korea
Research Site
Cheongju-si, , South Korea
Research Site
Daejeon, , South Korea
Research Site
Goyang-si, , South Korea
Research Site
Goyang-si, , South Korea
Research Site
Gwangju, , South Korea
Research Site
Gwangmyeong, , South Korea
Research Site
Gyeonggi-do, , South Korea
Research Site
Incheon, , South Korea
Research Site
Incheon, , South Korea
Research Site
Jeonju, , South Korea
Research Site
Jinju, , South Korea
Research Site
Seongnam, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Suwon, , South Korea
Research Site
Ulsan, , South Korea
Research Site
Yongin-si, , South Korea
Countries
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Related Links
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D168300008\_Study Report Synopsis\_redacted
Other Identifiers
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D1683R00008
Identifier Type: -
Identifier Source: org_study_id
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