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
- Diseases
- Type 2 diabetes
- 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
Sites (22)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.