Esgliteo Post Marketing Surveillance (PMS) in Korean Patients With Type 2 Diabetes Mellitus

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05130463
• Other study ID #: 1275-0028
• Status: Completed
• Start date: March 22, 2022
• Est. completion date: April 8, 2024

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 684
• Est. completion date: April 8, 2024
• Est. primary completion date: April 8, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• empagliflozin/linagliptin
tablet

Locations

Country	Name	City	State
Korea, Republic of	Woori-hospital	Bucheon-si	Gyeonggi-do
Korea, Republic of	Choi Won Rak Clinic	Busan
Korea, Republic of	MyungJi Medical Center	Busan
Korea, Republic of	Yonsei Clinic	Busan
Korea, Republic of	Choi Bongki Internal Medicine	Changwon-si	Gyeongsangnam-do
Korea, Republic of	Gyeongsang National Univ. Changwon Hospital	Changwon-si	Gyeongsangnam-do
Korea, Republic of	Seoul NIM Clinic	Changwon-si,	Gyeongsangnam-do,
Korea, Republic of	Cheonan Chungmu Hospital	Cheonan-si	Chungcheongnam-do
Korea, Republic of	Daejeon Endo Internal Medicine	Daejeon
Korea, Republic of	Good Morning Interanl medicine	Gwangju
Korea, Republic of	Park Clinic	Gwangju
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	Samsung Internal medicine	Hanam-si	Gyeonggi-do
Korea, Republic of	Chonnam National Univ. Hwasun Hospital	Hwasun-gun	Jeollanam-do
Korea, Republic of	IBS Medical Clinic	Incheon
Korea, Republic of	Dream Internal Medicine Clinic	Jeju-si
Korea, Republic of	Mokpo Gospel Internal Medicine Clinic	Mokpo-si	Jeollanam-do
Korea, Republic of	Park Chang Hyun Clinic	Mokpo-si	Jeollanam-do
Korea, Republic of	Park Il Jong Clinic	Mokpo-si	Jeollanam-do
Korea, Republic of	21Chospital	Seongnam-si	Gyeonggi-do
Korea, Republic of	Brrunmadi Orthopedics	Seongnam-si	Gyeonggi-do
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do
Korea, Republic of	ST.Mary's Will Hospital	Seongnam-si	Gyeonggi-do
Korea, Republic of	CBY Endocrine & Internal Medicine	Seoul
Korea, Republic of	D&F Hospital	Seoul
Korea, Republic of	Kyung Hee University Medical Center	Seoul
Korea, Republic of	Yonsei Checkup Clinic	Seoul
Korea, Republic of	Yeongju gidok hospital	Yeongju-si	Gyeongsangbuk-do
Korea, Republic of	Yeosu Jeil Hospital	Yeosu-si	Jeollanam-do

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurence of adverse events	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)	up to 24 weeks
Primary	Change from baseline in HbA1c after 12 weeks of treatment		at baseline, at week 12
Primary	Change from baseline in HbA1c after 24 weeks of treatment		at baseline, at week 24
Secondary	Occurrence of treat to target effectiveness response after 12 weeks	effectiveness response is an Glucosylated Hemoglobin (HbA1c) under treatment of < 7%	at week 12
Secondary	Occurrence of treat to target effectiveness response after 24 weeks	effectiveness response is an Glucosylated Hemoglobin (HbA1c) under treatment of < 7%	at week 24
Secondary	Occurrence of relative effectiveness response after 12 weeks	relative effectiveness response is HbA1c lowering by at least 0.5%	at week 12
Secondary	Occurrence of relative effectiveness response after 24 weeks	relative effectiveness response is HbA1c lowering by at least 0.5%	at week 24
Secondary	Change from baseline in fasting plasma glucose (FPG) after 12 weeks of treatment		at baseline, at week 12
Secondary	Change from baseline in fasting plasma glucose (FPG) after 24 weeks of treatment		at baseline, at week 24
Secondary	Change from baseline in body weight after 12 weeks weeks of treatment		at baseline, at week 12
Secondary	Change from baseline in body weight after 24 weeks weeks of treatment		at baseline, at week 24
Secondary	Change from baseline in systolic blood pressure after 12 weeks of treatment		at baseline, at week 12
Secondary	Change from baseline in diastolic blood pressure after 12 weeks of treatment		at baseline, at week 12
Secondary	Change from baseline in systolic blood pressure after 24 weeks of treatment		at baseline, at week 24
Secondary	Change from baseline in diastolic blood pressure after 24 weeks of treatment		at baseline, at week 24
Secondary	Number of Participants with Final effectiveness evaluation	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').	up to 24 weeks

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