QTERN (SAXAGLIPTIN/DAPAGLIFLOZIN FDC) Regulatory Post-Marketing Surveillance
- Conditions
- Type 2 Diabetes Mellitus
- Registration Number
- NCT05160974
- Lead Sponsor
- AstraZeneca
- 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.
- Detailed Description
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)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 679
- 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.
- 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method • Incidence of unexpected adverse drug reactions in patients who are treated with Qtern 12 or 24 weeks • Incidence (%) of AEs 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 • Severity of AE 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 • Incidence (%) of SAEs 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
- Secondary Outcome Measures
Name Time Method • Change in abdominal circumference 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 body weight during the observation period 12 or 24 weeks • Change in HbA1c during the observation period 12 or 24 weeks • Change in FPG during the observation period 12 or 24 weeks • Overall assessment on the outcome of the treatment by investigators 12 or 24 weeks 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• Clinically significant results from blood chemistry test 12 or 24 weeks Clinically significance will be determined as per the investigators clinical judgement based on routine clinical practice.
• Clinically significant results from complete blood count test 12 or 24 weeks Clinically significance will be determined as per the investigators clinical judgement based on routine clinical practice.
• Clinically significant results from urinalysis 12 or 24 weeks Clinically significance will be determined as per the investigators clinical judgement based on routine clinical practice.
Trial Locations
- Locations (1)
Research Site
🇰🇷Yongin-si, Korea, Republic of