An observational study in Type 2 Diabetes Mellitus, sponsored by AstraZeneca. Completed at 34 sites in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2025-03-06.
Sponsored by AstraZeneca · Observational
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.
As part of a post approval commitment, the MFDS has requested a post-marketing surveillance program to characterize safety in patients who are treated with Qtern for T2DM by physicians in the normal clinical practice setting. This study is designed to confirm assess the known safety profile or identify previously unsuspected adverse reactions and to evaluate the effectiveness of Qtern under conditions of routine daily medical practice in Korea.
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)
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's enrollment of 679 is above the median of 300 across 1,588 observational studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
• Incidence (%) of AEs in patients who are treated with Qtern
Time frame: 12 or 24 weeks
• Nature of AE in patients who are treated with Qtern
Time frame: 12 or 24 weeks
• Nature of unexpected adverse drug reactions in patients who are treated with Qtern
Time frame: 12 or 24 weeks
• Severity of AE in patients who are treated with Qtern
Time frame: 12 or 24 weeks
• Incidence of unexpected adverse drug reactions in patients who are treated with Qtern
Time frame: 12 or 24 weeks
• Severity of unexpected adverse drug reactions in patients who are treated with Qtern
Time frame: 12 or 24 weeks
• Incidence (%) of SAEs in patients who are treated with Qtern
Time frame: 12 or 24 weeks
• Change in HbA1c during the observation period
Time frame: 12 or 24 weeks
• Change in FPG during the observation period
Time frame: 12 or 24 weeks
• Change of PPG-2hr during the observation period
Time frame: 12 or 24 weeks
• Change in blood pressure during the observation period
Time frame: 12 or 24 weeks
• Change in abdominal circumference during the observation period
Time frame: 12 or 24 weeks
• Change in body weight during the observation period
Time frame: 12 or 24 weeks
• Overall assessment on the outcome of the treatment by investigators
The overall investigator's assessment on the outcome will be based on the investigator's clinical judgment and classified as below criteria issued by the Korean Ministry of Food and Drug Safety (MFDS): * Improved: Signs and symptoms are significantly improved or maintenance effect * Unchanged: Improvement in signs and symptoms is not significant or there is no change in signs and symptoms * Worsened: Signs and symptoms are worsened * Assessment impossible: Assessment is impossible because the surveillance drug was discontinued before 12 weeks
Time frame: 12 or 24 weeks
• Clinically significant results from blood chemistry test
Clinically significance will be determined as per the investigators clinical judgement based on routine clinical practice.
Time frame: 12 or 24 weeks
• Clinically significant results from complete blood count test
Clinically significance will be determined as per the investigators clinical judgement based on routine clinical practice.
Time frame: 12 or 24 weeks
• Clinically significant results from urinalysis
Clinically significance will be determined as per the investigators clinical judgement based on routine clinical practice.
Time frame: 12 or 24 weeks
Plan to share: Yes — 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.
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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