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NCT05160974Completed

QTERN (SAXAGLIPTIN/DAPAGLIFLOZIN FDC) Regulatory Post-Marketing Surveillance

Source: ClinicalTrials.gov · Last updated 6 Mar 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
679 (actual)
First submitted
4 Nov 2021
Start date
30 Dec 2021
Primary completion date
1 Apr 2024
Lead sponsor
AstraZeneca
NCT number
NCT05160974

What you commit to

  • Study type: Observational
  • Participants enrolled: 679
  • From 30 Dec 2021 to the primary completion date, 1 Apr 2024
  • 22 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients treated with Qtern outside of the locally approved Prescription Information in Korea

Other

  • Patients with contraindications for the use of Qtern (as described in the Korean Prescription Information)

Who the study is looking for

  • Patients aged 19 years and older
  • Patients with T2DM eligible for treatment with Qtern as indicated in the locally approved prescribing information
  • 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.

Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (22)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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BusanSouth KoreaUnknown status
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ChangwonSouth KoreaUnknown status
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Changwon-siSouth KoreaUnknown status
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Cheongju-siSouth KoreaUnknown status
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DaejeonSouth KoreaUnknown status
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GimcheonSouth KoreaUnknown status
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Goyang-siSouth KoreaUnknown status
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GwangjuSouth KoreaUnknown status
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GwangmyeongSouth KoreaUnknown status
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Gyeonggi-doSouth KoreaUnknown status
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IncheonSouth KoreaUnknown status
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Jeju-doSouth KoreaUnknown status
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JeonjuSouth KoreaUnknown status
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JinjuSouth KoreaUnknown status
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Pyeongtaek-siSouth KoreaUnknown status
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SeongnamSouth KoreaUnknown status
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Seosan CitySouth KoreaUnknown status
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SeoulSouth KoreaUnknown status
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SuwonSouth KoreaUnknown status
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UlsanSouth KoreaUnknown status
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Yeongcheon-siSouth KoreaUnknown status
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Yongin-siSouth KoreaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.