Esgliteo Post Marketing Surveillance (PMS) in Korean Patients With Type 2 Diabetes Mellitus
- Registration Number
- NCT05130463
- Lead Sponsor
- Boehringer Ingelheim
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1053
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients diagnosed with type 2 diabetes mellitus empagliflozin/linagliptin -
- Primary Outcome Measures
Name Time Method Occurence of adverse events up to 24 weeks Adverse events - including unexpected adverse events, serious adverse events, drug-related adverse events, non-serious adverse drug reactions, adverse events of special interest, adverse events leading to discontinuation, adverse events by intensity/outcome of the events/causality)
Change from baseline in HbA1c after 24 weeks of treatment at baseline, at week 24 Change from baseline in HbA1c after 12 weeks of treatment at baseline, at week 12
- Secondary Outcome Measures
Name Time Method Change from baseline in body weight after 12 weeks weeks of treatment at baseline, at week 12 Change from baseline in systolic blood pressure after 12 weeks of treatment at baseline, at week 12 Occurrence of treat to target effectiveness response after 24 weeks at week 24 effectiveness response is an Glucosylated Hemoglobin (HbA1c) under treatment of \< 7%
Occurrence of treat to target effectiveness response after 12 weeks at week 12 effectiveness response is an Glucosylated Hemoglobin (HbA1c) under treatment of \< 7%
Change from baseline in body weight after 24 weeks weeks of treatment at baseline, at week 24 Change from baseline in diastolic blood pressure after 24 weeks of treatment at baseline, at week 24 Number of Participants with Final effectiveness evaluation up to 24 weeks Final effectiveness will be evaluated as 'improved', 'unchanged', 'aggravated' or 'unassessable' based on the physician's evaluation of the overall participant's disease related factors after 24 weeks. 'Improved' will be if determined as there is any effect of maintaining or improving disease related factors, 'unchanged' will be if disease related factors have not been changed compared with before administration, and not determined as there is any effect of maintaining symptoms. 'Aggravated' will be if disease related factors are worse than before administration and 'unassessable' will be if it cannot be determined due to insufficient information collected. 'Improved', 'unchanged', 'aggravated' will be further categorized as 'effective' ('improved') and 'ineffective' ('unchanged' and 'aggravated').
Occurrence of relative effectiveness response after 12 weeks at week 12 relative effectiveness response is HbA1c lowering by at least 0.5%
Change from baseline in fasting plasma glucose (FPG) after 12 weeks of treatment at baseline, at week 12 Occurrence of relative effectiveness response after 24 weeks at week 24 relative effectiveness response is HbA1c lowering by at least 0.5%
Change from baseline in fasting plasma glucose (FPG) after 24 weeks of treatment at baseline, at week 24 Change from baseline in diastolic blood pressure after 12 weeks of treatment at baseline, at week 12 Change from baseline in systolic blood pressure after 24 weeks of treatment at baseline, at week 24
Trial Locations
- Locations (30)
Cheonan Chungmu Hospital
🇰🇷Cheonan-si, Chungcheongnam-do, Korea, Republic of
Yeosu Jeil Hospital
🇰🇷Yeosu-si, Jeollanam-do, Korea, Republic of
Gyeongsang National Univ. Changwon Hospital
🇰🇷Changwon-si, Gyeongsangnam-do, Korea, Republic of
Brrunmadi Orthopedics
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of
Park Chang Hyun Clinic
🇰🇷Mokpo-si, Jeollanam-do, Korea, Republic of
Daejeon Endo Internal Medicine
🇰🇷Daejeon, Korea, Republic of
Kyung Hee University Medical Center
🇰🇷Seoul, Korea, Republic of
ST.Mary's Will Hospital
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of
CBY Endocrine & Internal Medicine
🇰🇷Seoul, Korea, Republic of
Choi Bongki Internal Medicine
🇰🇷Changwon-si, Gyeongsangnam-do, Korea, Republic of
Good Morning Interanl medicine
🇰🇷Gwangju, Korea, Republic of
Samsung Internal medicine
🇰🇷Hanam-si, Gyeonggi-do, Korea, Republic of
Seoul NIM Clinic
🇰🇷Changwon-si,, Gyeongsangnam-do,, Korea, Republic of
Yeongju gidok hospital
🇰🇷Yeongju-si, Gyeongsangbuk-do, Korea, Republic of
Yonsei Clinic
🇰🇷Busan, Korea, Republic of
IBS Medical Clinic
🇰🇷Incheon, Korea, Republic of
Woori-hospital
🇰🇷Bucheon-si, Gyeonggi-do, Korea, Republic of
Chonnam National Univ. Hwasun Hospital
🇰🇷Hwasun-gun, Jeollanam-do, Korea, Republic of
Mokpo Gospel Internal Medicine Clinic
🇰🇷Mokpo-si, Jeollanam-do, Korea, Republic of
Choi Won Rak Clinic
🇰🇷Busan, Korea, Republic of
21Chospital
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of
MyungJi Medical Center
🇰🇷Busan, Korea, Republic of
Park Clinic
🇰🇷Gwangju, Korea, Republic of
Dream Internal Medicine Clinic
🇰🇷Jeju-si, Korea, Republic of
Yonsei Checkup Clinic
🇰🇷Seoul, Korea, Republic of
Seo Jung Hwa Internal medicine
🇰🇷Gwangmyeong-si, Gyeonggi-do, Korea, Republic of
Dr.Yoon's Clinic
🇰🇷Gyeongsan-si, Gyeongsangbuk-do, Korea, Republic of
Park Il Jong Clinic
🇰🇷Mokpo-si, Jeollanam-do, Korea, Republic of
D&F Hospital
🇰🇷Seoul, Korea, Republic of