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

Study Overview
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Brief Summary
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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
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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)

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

Conditions
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Type 2 Diabetes Mellitus

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • 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 | 
| • Change in body weight during the observation period |  | 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 | 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. | 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. | 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. | 12 or 24 weeks |