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

AstraZeneca

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Study type: Observational

Funder types: Industry

Identifiers

NCT05160974

D1683R00008

Details and patient eligibility

About

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.

Full 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)

Enrollment: 679 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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)