NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

CompletedN/A

Sponsor: AstraZeneca

Conditions: Type 2 Diabetes Mellitus

Countries: South Korea

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.

Eligibility overview

Sex: ALL

Age: 19 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

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)

Locations (34)

Changwon-si, South Korea, South Korea
Gimcheon, South Korea, South Korea
Jeju-do, South Korea, South Korea
Jeonju, South Korea, South Korea
Pyeongtaek-si, South Korea, South Korea
Seosan City, South Korea, South Korea
Yeongcheon-si, South Korea, South Korea
Busan, South Korea
Busan, South Korea
Busan, South Korea
Changwon, South Korea
Cheongju-si, South Korea
Daejeon, South Korea
Goyang-si, South Korea
Goyang-si, South Korea
Gwangju, South Korea
Gwangmyeong, South Korea
Gyeonggi-do, South Korea
Incheon, South Korea
Incheon, South Korea
Jeonju, South Korea
Jinju, South Korea
Seongnam, South Korea
Seoul, South Korea
Seoul, South Korea
Seoul, South Korea
Seoul, South Korea
Seoul, South Korea
Seoul, South Korea
Seoul, South Korea
+ 4 more on CT.gov