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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05160974
• Other study ID #: D1683R00008
• Status: Completed
• Start date: December 30, 2021
• Est. completion date: April 1, 2024

Study information

• Verified date: May 2024
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 679
• Est. completion date: April 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Locations

Country	Name	City	State
Korea, Republic of	Research Site	Busan
Korea, Republic of	Research Site	Busan
Korea, Republic of	Research Site	Busan
Korea, Republic of	Research Site	Changwon
Korea, Republic of	Research Site	Changwon-si	South Korea
Korea, Republic of	Research Site	Cheongju
Korea, Republic of	Research Site	Daejeon
Korea, Republic of	Research Site	Gimcheon-si	South Korea
Korea, Republic of	Research Site	Goyang-si
Korea, Republic of	Research Site	Goyang-si
Korea, Republic of	Research Site	Gwangju
Korea, Republic of	Research Site	Gwangmyeong
Korea, Republic of	Research Site	Gyeonggi-do
Korea, Republic of	Research Site	Incheon
Korea, Republic of	Research Site	Incheon
Korea, Republic of	Research Site	Jeju-do	South Korea
Korea, Republic of	Research Site	Jeonju
Korea, Republic of	Research Site	Jeonju-si	South Korea
Korea, Republic of	Research Site	Jinju-si
Korea, Republic of	Research Site	Pyeongtaek-si	South Korea
Korea, Republic of	Research Site	Seongnam
Korea, Republic of	Research Site	Seosan-si	South Korea
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Suwon-si
Korea, Republic of	Research Site	Ulsan
Korea, Republic of	Research Site	Yeongcheon-si	South Korea
Korea, Republic of	Research Site	Yongin-si

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• Incidence (%) of AEs in patients who are treated with Qtern		12 or 24 weeks
Primary	• Nature of AE in patients who are treated with Qtern		12 or 24 weeks
Primary	• Nature of unexpected adverse drug reactions in patients who are treated with Qtern		12 or 24 weeks
Primary	• Severity of AE in patients who are treated with Qtern		12 or 24 weeks
Primary	• Incidence of unexpected adverse drug reactions in patients who are treated with Qtern		12 or 24 weeks
Primary	• Severity of unexpected adverse drug reactions in patients who are treated with Qtern		12 or 24 weeks
Primary	• Incidence (%) of SAEs in patients who are treated with Qtern		12 or 24 weeks
Secondary	• Change in HbA1c during the observation period		12 or 24 weeks
Secondary	• Change in FPG during the observation period		12 or 24 weeks
Secondary	• Change of PPG-2hr during the observation period		12 or 24 weeks
Secondary	• Change in blood pressure during the observation period		12 or 24 weeks
Secondary	• Change in abdominal circumference during the observation period		12 or 24 weeks
Secondary	• Change in body weight during the observation period		12 or 24 weeks
Secondary	• 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
Secondary	• 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
Secondary	• 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
Secondary	• 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