Clinical trial NCT05130463: Esgliteo Post Marketing Surveillance (PMS) in Korean Patients With Type 2 Diabetes Mellitus
Official title: A Regulatory Requirement Non-interventional Study to Monitor the Safety and Effectiveness of Esgliteo (Empagliflozin/Linagliptin, 10/5mg, 25/5mg) in Korean Patients With Type 2 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2021-11-23
Enrollment: 1053
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with type 2 diabetes mellitus in Korea.

Brief summary: The objectives of this study are to monitor the safety and effectiveness of Esgliteo in Korean patients with type 2 diabetes mellitus in a routine clinical practice setting.


Eligibility criteria: Inclusion Criteria:

* Patients who have started at first time on Esgliteo in accordance with the approved label in Korea
* Age ≥19 years at enrolment
* Patients who have signed on the data release consent form

Exclusion Criteria:

* Patients with previous exposure to Esgliteo
* Patients with hypersensitivity to the empagliflozin and/or linagliptin or any of the excipients
* Patients with type 1 diabetes or diabetic ketoacidosis
* Patients with estimated Glomerular Filtration Rate (eGFR) \< 45 mL/min/1.73m2, end stage renal disease, or patient on dialysis
* Patients for whom empagliflozin/linagliptin is contraindicated according to the local label of Esgliteo

Primary outcomes:
measure: Occurence of adverse events
timeFrame: up to 24 weeks
measure: Change from baseline in HbA1c after 12 weeks of treatment
timeFrame: at baseline, at week 12
measure: Change from baseline in HbA1c after 24 weeks of treatment
timeFrame: at baseline, at week 24
Secondary outcomes:
measure: Occurrence of treat to target effectiveness response after 12 weeks
timeFrame: at week 12
measure: Occurrence of treat to target effectiveness response after 24 weeks
timeFrame: at week 24
measure: Occurrence of relative effectiveness response after 12 weeks
timeFrame: at week 12
measure: Occurrence of relative effectiveness response after 24 weeks
timeFrame: at week 24
measure: Change from baseline in fasting plasma glucose (FPG) after 12 weeks of treatment
timeFrame: at baseline, at week 12
measure: Change from baseline in fasting plasma glucose (FPG) after 24 weeks of treatment
timeFrame: at baseline, at week 24
measure: Change from baseline in body weight after 12 weeks weeks of treatment
timeFrame: at baseline, at week 12
measure: Change from baseline in body weight after 24 weeks weeks of treatment
timeFrame: at baseline, at week 24
measure: Change from baseline in systolic blood pressure after 12 weeks of treatment
timeFrame: at baseline, at week 12
measure: Change from baseline in diastolic blood pressure after 12 weeks of treatment
timeFrame: at baseline, at week 12
measure: Change from baseline in systolic blood pressure after 24 weeks of treatment
timeFrame: at baseline, at week 24
measure: Change from baseline in diastolic blood pressure after 24 weeks of treatment
timeFrame: at baseline, at week 24
measure: Number of Participants with Final effectiveness evaluation
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Cheonan-si
country: Korea, Republic of
facility: Cheonan Chungmu Hospital
state: Chungcheongnam-do
city: Bucheon-si
country: Korea, Republic of
facility: Woori-hospital
state: Gyeonggi-do
city: Gwangmyeong-si
country: Korea, Republic of
facility: Seo Jung Hwa Internal medicine
state: Gyeonggi-do
city: Hanam-si
country: Korea, Republic of
facility: Samsung Internal medicine
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Brrunmadi Orthopedics
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: ST.Mary's Will Hospital
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: 21Chospital
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Gyeongsan-si
country: Korea, Republic of
facility: Dr.Yoon's Clinic
state: Gyeongsangbuk-do
city: Yeongju-si
country: Korea, Republic of
facility: Yeongju gidok hospital
state: Gyeongsangbuk-do
city: Changwon-si,
country: Korea, Republic of
facility: Seoul NIM Clinic
state: Gyeongsangnam-do,
city: Changwon-si
country: Korea, Republic of
facility: Choi Bongki Internal Medicine
state: Gyeongsangnam-do
city: Changwon-si
country: Korea, Republic of
facility: Gyeongsang National Univ. Changwon Hospital
state: Gyeongsangnam-do
city: Hwasun-gun
country: Korea, Republic of
facility: Chonnam National Univ. Hwasun Hospital
state: Jeollanam-do
city: Mokpo-si
country: Korea, Republic of
facility: Park Chang Hyun Clinic
state: Jeollanam-do
city: Mokpo-si
country: Korea, Republic of
facility: Mokpo Gospel Internal Medicine Clinic
state: Jeollanam-do
city: Mokpo-si
country: Korea, Republic of
facility: Park Il Jong Clinic
state: Jeollanam-do
city: Yeosu-si
country: Korea, Republic of
facility: Yeosu Jeil Hospital
state: Jeollanam-do
city: Busan
country: Korea, Republic of
facility: Yonsei Clinic
city: Busan
country: Korea, Republic of
facility: MyungJi Medical Center
city: Busan
country: Korea, Republic of
facility: Choi Won Rak Clinic
city: Daejeon
country: Korea, Republic of
facility: Daejeon Endo Internal Medicine
city: Gwangju
country: Korea, Republic of
facility: Good Morning Interanl medicine
city: Gwangju
country: Korea, Republic of
facility: Park Clinic
city: Incheon
country: Korea, Republic of
facility: IBS Medical Clinic
city: Jeju-si
country: Korea, Republic of
facility: Dream Internal Medicine Clinic
city: Seoul
country: Korea, Republic of
facility: D&F Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Medical Center
city: Seoul
country: Korea, Republic of
facility: Yonsei Checkup Clinic
city: Seoul
country: Korea, Republic of
facility: CBY Endocrine & Internal Medicine
Study officials:
References: