QTERN (SAXAGLIPTIN/DAPAGLIFLOZIN FDC) Regulatory Post-Marketing Surveillance
1 other identifier
observational
679
1 country
34
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2021
Typical duration for all trials
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 4, 2021
CompletedFirst Posted
Study publicly available on registry
December 16, 2021
CompletedStudy Start
First participant enrolled
December 30, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2024
CompletedMarch 6, 2025
March 1, 2025
2.3 years
November 4, 2021
March 5, 2025
Conditions
Outcome Measures
Primary Outcomes (7)
• Incidence (%) of AEs in patients who are treated with Qtern
12 or 24 weeks
• Nature of AE in patients who are treated with Qtern
12 or 24 weeks
• Nature of unexpected adverse drug reactions in patients who are treated with Qtern
12 or 24 weeks
• Severity of AE in patients who are treated with Qtern
12 or 24 weeks
• Incidence of unexpected adverse drug reactions in patients who are treated with Qtern
12 or 24 weeks
• Severity of unexpected adverse drug reactions in patients who are treated with Qtern
12 or 24 weeks
• Incidence (%) of SAEs in patients who are treated with Qtern
12 or 24 weeks
Secondary Outcomes (10)
• Change in HbA1c during the observation period
12 or 24 weeks
• Change in FPG during the observation period
12 or 24 weeks
• Change of PPG-2hr during the observation period
12 or 24 weeks
• Change in blood pressure during the observation period
12 or 24 weeks
• Change in abdominal circumference during the observation period
12 or 24 weeks
- +5 more secondary outcomes
Eligibility Criteria
Adult patients who are diagnosed with T2DM eligible for the treatment with Qtern (5 mg saxagliptin/10 mg dapagliflozin) according to prescription information approved by MFDS and as decided by the investigator.
You may qualify if:
- 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.
You may not qualify if:
- Patients treated with Qtern outside of the locally approved Prescription Information in Korea
- Patients with contraindications for the use of Qtern (as described in the Korean Prescription Information)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (34)
Research Site
Changwon-si, South Korea, 51139, South Korea
Research Site
Gimcheon, South Korea, 39550, South Korea
Research Site
Jeju-do, South Korea, 63241, South Korea
Research Site
Jeonju, South Korea, 54999, South Korea
Research Site
Pyeongtaek-si, South Korea, 17909, South Korea
Research Site
Seosan City, South Korea, 31931, South Korea
Research Site
Yeongcheon-si, South Korea, 38885, South Korea
Research Site
Busan, 47261, South Korea
Research Site
Busan, 48092, South Korea
Research Site
Busan, 49326, South Korea
Research Site
Changwon, 51495, South Korea
Research Site
Cheongju-si, 28325, South Korea
Research Site
Daejeon, 34944, South Korea
Research Site
Goyang-si, 10588, South Korea
Research Site
Goyang-si, 13620, South Korea
Research Site
Gwangju, 12759, South Korea
Research Site
Gwangmyeong, 14220, South Korea
Research Site
Gyeonggi-do, 16825, South Korea
Research Site
Incheon, 21550, South Korea
Research Site
Incheon, 22372, South Korea
Research Site
Jeonju, 54807, South Korea
Research Site
Jinju, 52683, South Korea
Research Site
Seongnam, 13338, South Korea
Research Site
Seoul, 02841, South Korea
Research Site
Seoul, 04763, South Korea
Research Site
Seoul, 05055, South Korea
Research Site
Seoul, 05372, South Korea
Research Site
Seoul, 07385, South Korea
Research Site
Seoul, 07441, South Korea
Research Site
Seoul, 07694, South Korea
Research Site
Seoul, 08832, South Korea
Research Site
Suwon, 16441, South Korea
Research Site
Ulsan, 44686, South Korea
Research Site
Yongin-si, 17049, South Korea
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 4, 2021
First Posted
December 16, 2021
Study Start
December 30, 2021
Primary Completion
April 1, 2024
Study Completion
April 1, 2024
Last Updated
March 6, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.