Clinical trial NCT05160974: QTERN (SAXAGLIPTIN/DAPAGLIFLOZIN FDC) Regulatory Post-Marketing Surveillance
Official title: QTERN (SAXAGLIPTIN/DAPAGLIFLOZIN FDC) Regulatory Post-Marketing Surveillance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2021-12-16
Enrollment: 679
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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)

Eligibility criteria: 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)

Primary outcomes:
measure: • Incidence (%) of AEs in patients who are treated with Qtern
timeFrame: 12 or 24 weeks
measure: • Nature of AE in patients who are treated with Qtern
timeFrame: 12 or 24 weeks
measure: • Nature of unexpected adverse drug reactions in patients who are treated with Qtern
timeFrame: 12 or 24 weeks
measure: • Severity of AE in patients who are treated with Qtern
timeFrame: 12 or 24 weeks
measure: • Incidence of unexpected adverse drug reactions in patients who are treated with Qtern
timeFrame: 12 or 24 weeks
measure: • Severity of unexpected adverse drug reactions in patients who are treated with Qtern
timeFrame: 12 or 24 weeks
measure: • Incidence (%) of SAEs in patients who are treated with Qtern
timeFrame: 12 or 24 weeks
Secondary outcomes:
measure: • Change in HbA1c during the observation period
timeFrame: 12 or 24 weeks
measure: • Change in FPG during the observation period
timeFrame: 12 or 24 weeks
measure: • Change of PPG-2hr during the observation period
timeFrame: 12 or 24 weeks
measure: • Change in blood pressure during the observation period
timeFrame: 12 or 24 weeks
measure: • Change in abdominal circumference during the observation period
timeFrame: 12 or 24 weeks
measure: • Change in body weight during the observation period
timeFrame: 12 or 24 weeks
measure: • Overall assessment on the outcome of the treatment by investigators
timeFrame: 12 or 24 weeks
measure: • Clinically significant results from blood chemistry test
timeFrame: 12 or 24 weeks
measure: • Clinically significant results from complete blood count test
timeFrame: 12 or 24 weeks
measure: • Clinically significant results from urinalysis
timeFrame: 12 or 24 weeks
Other outcomes:
Locations:
city: Changwon-si
country: Korea, Republic of
facility: Research Site
state: South Korea
city: Gimcheon-si
country: Korea, Republic of
facility: Research Site
state: South Korea
city: Jeju-do
country: Korea, Republic of
facility: Research Site
state: South Korea
city: Jeonju-si
country: Korea, Republic of
facility: Research Site
state: South Korea
city: Pyeongtaek-si
country: Korea, Republic of
facility: Research Site
state: South Korea
city: Seosan-si
country: Korea, Republic of
facility: Research Site
state: South Korea
city: Yeongcheon-si
country: Korea, Republic of
facility: Research Site
state: South Korea
city: Busan
country: Korea, Republic of
facility: Research Site
city: Busan
country: Korea, Republic of
facility: Research Site
city: Busan
country: Korea, Republic of
facility: Research Site
city: Changwon
country: Korea, Republic of
facility: Research Site
city: Cheongju
country: Korea, Republic of
facility: Research Site
city: Daejeon
country: Korea, Republic of
facility: Research Site
city: Goyang-si
country: Korea, Republic of
facility: Research Site
city: Goyang-si
country: Korea, Republic of
facility: Research Site
city: Gwangju
country: Korea, Republic of
facility: Research Site
city: Gwangmyeong
country: Korea, Republic of
facility: Research Site
city: Gyeonggi-do
country: Korea, Republic of
facility: Research Site
city: Incheon
country: Korea, Republic of
facility: Research Site
city: Incheon
country: Korea, Republic of
facility: Research Site
city: Jeonju
country: Korea, Republic of
facility: Research Site
city: Jinju-si
country: Korea, Republic of
facility: Research Site
city: Seongnam
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Suwon-si
country: Korea, Republic of
facility: Research Site
city: Ulsan
country: Korea, Republic of
facility: Research Site
city: Yongin-si
country: Korea, Republic of
facility: Research Site
Study officials:
References: