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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Empagliflozin/Linagliptin

• Study Type: Observational
• Enrollment (Actual): 1053

Contacts and Locations

Study Locations

• South Korea
  • Busan, South Korea, 46555
    • Yonsei Clinic
  • Busan, South Korea, 46726
    • MyungJi Medical Center
  • Busan, South Korea, 49374
    • Choi Won Rak Clinic
  • Daejeon, South Korea, 35220
    • Daejeon Endo Internal Medicine
  • Gwangju, South Korea, 61675
    • Good Morning Interanl medicine
  • Gwangju, South Korea, 62258
    • Park Clinic
  • Incheon, South Korea, 22006
    • IBS Medical Clinic
  • Jeju City, South Korea, 63083
    • Dream Internal Medicine Clinic
  • Seoul, South Korea, 02089
    • D&F Hospital
  • Seoul, South Korea, 02447
    • Kyung Hee University Medical Center
  • Seoul, South Korea, 05719
    • Yonsei Checkup Clinic
  • Seoul, South Korea, 08783
    • CBY Endocrine & Internal Medicine
  • Chungcheongnam-do
    • Cheonan-si, Chungcheongnam-do, South Korea, 31181
      • Cheonan Chungmu Hospital
  • Gyeonggi-do
    • Bucheon-si, Gyeonggi-do, South Korea, 14706
      • Woori-hospital
    • Gwangmyeong, Gyeonggi-do, South Korea, 14248
      • Seo Jung Hwa Internal medicine
    • Hanam, Gyeonggi-do, South Korea, 12927
      • Samsung Internal medicine
    • Seongnam-si, Gyeonggi-do, South Korea, 13182
      • Brrunmadi Orthopedics
    • Seongnam-si, Gyeonggi-do, South Korea, 13313
      • ST.Mary's Will Hospital
    • Seongnam-si, Gyeonggi-do, South Korea, 13577
      • 21Chospital
    • Seongnam-si, Gyeonggi-do, South Korea, 13620
      • Seoul National University Bundang Hospital
  • Gyeongsangbuk-do
    • Gyeongsan-si, Gyeongsangbuk-do, South Korea, 38657
      • Dr.Yoon's Clinic
    • Yeongju, Gyeongsangbuk-do, South Korea, 36096
      • Yeongju gidok hospital
  • Gyeongsangnam-do
    • Changwon-si, Gyeongsangnam-do, South Korea, 51449
      • Choi Bongki Internal Medicine
    • Changwon-si, Gyeongsangnam-do, South Korea, 51472
      • Gyeongsang National Univ. Changwon Hospital
    • Changwon-si,, Gyeongsangnam-do, South Korea, 51595
      • Seoul NIM Clinic
  • Jeollanam-do
    • Hwasun-gun, Jeollanam-do, South Korea, 58128
      • Chonnam National Univ. Hwasun Hospital
    • Mokpo-si, Jeollanam-do, South Korea, 58640
      • Park Chang Hyun Clinic
    • Mokpo-si, Jeollanam-do, South Korea, 58664
      • Mokpo Gospel Internal Medicine Clinic
    • Mokpo-si, Jeollanam-do, South Korea, 58707
      • Park Il Jong Clinic
    • Yeosu, Jeollanam-do, South Korea, 59677
      • Yeosu Jeil Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients diagnosed with type 2 diabetes mellitus in Korea.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients diagnosed with type 2 diabetes mellitus; Patients aged 19 years or older, diagnosed with type 2 diabetes mellitus in Korea, who initiated treatment with ESGLITEO® for the first time in accordance with the locally approved label.	Drug: Empagliflozin/Linagliptin; Participants received Empagliflozin 10mg or 25mg and Linagliptin 5mg (Fixed Dose) Film-coated tablets orally once daily with or without food.; Other Names: Esgliteo®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All Reported Adverse Events Collected From Subjects Taking at Least One Dose of ESGLITEO®	These include those who signed the data release consent form to participate in this study as subject, took Esgliteo once at least, and were followed up by the physician once or more.	From first trial drug administration up to 24 weeks.
Change From Baseline in Glycosylated Hemoglobin (HbA1c) After 12 Weeks of Treatment	The mean change from baseline in glycosylated hemoglobin (HbA1c) after 12 weeks of treatment is presented.	From the first trial drug administration up to 12 weeks.
Change From Baseline in Glycosylated Hemoglobin (HbA1c) After 24 Weeks of Treatment	The mean change from baseline in glycosylated hemoglobin (HbA1c) after 24 weeks of treatment is presented.	From the first trial drug administration up to 24 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With HbA1c Reaching Less Than 7% From Baseline (Target Effectiveness Response Rate) After 12 Weeks of Treatment	The percentage of patients whose glycosylated hemoglobin (HbA1c) levels dropped below 7% at 12 weeks following trial drug administration are presented.	From the first trial drug administration up to 12 weeks.
Percentage of Participants With HbA1c Reaching Less Than 7% From Baseline (Target Effectiveness Response Rate) After 24 Weeks of Treatment	The percentage of patients whose glycosylated hemoglobin (HbA1c) levels dropped below 7% at 24 weeks following trial drug administration are presented.	From the first trial drug administration up to 24 weeks.
Percentage of Participants With Occurrence of Relative Effectiveness Response After 12 Weeks of Treatment	Relative effectiveness was defined as participants whose HbA1c decreased by at least 0.5% (relative effectiveness response rate) at 12 weeks after administration of ESGLITEO®.	From the first trial drug administration up to 12 weeks.
Percentage of Participants With Occurrence of Relative Effectiveness Response After 24 Weeks of Treatment	Relative effectiveness was defined as participants whose HbA1c decreased by at least 0.5% (relative effectiveness response rate) at 24 weeks after administration of ESGLITEO®.	From the first trial drug administration up to 24 weeks.
Change From Baseline in Fasting Plasma Glucose (FPG) After 12 Weeks of Treatment	Change from baseline in fasting plasma glucose (FPG) of participants after 12 weeks of treatment is presented.	From the first trial drug administration up to 12 weeks.
Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks of Treatment	Change from baseline in fasting plasma glucose (FPG) of participants after 24 weeks of treatment is presented.	From the first trial drug administration up to 24 weeks.
Change From Baseline in Body Weight After 12 Weeks of Treatment	Change from baseline in body weight of participants after 12 weeks of treatment is presented.	From the first trial drug administration up to 12 weeks.
Change From Baseline in Body Weight After 24 Weeks of Treatment	Change from baseline in body weight of participants after 24 weeks of treatment is presented.	From the first trial drug administration up to 24 weeks.
Change From Baseline in Blood Pressure (Systolic Blood Pressure [SBP], Diastolic Blood Pressure [DBP]) After 12 Weeks of Treatment	Mean change from baseline in blood pressure (systolic blood pressure [SBP], diastolic blood pressure [DBP]) of participants after 12 weeks of treatment is presented.	From the first trial drug administration up to 12 weeks.
Change From Baseline in Blood Pressure (Systolic Blood Pressure [SBP], Diastolic Blood Pressure [DBP]) After 24 Weeks of Treatment	Mean change from baseline in blood pressure (systolic blood pressure [SBP], diastolic blood pressure [DBP]) of participants after 24 weeks of treatment is presented.	From the first trial drug administration up to 24 weeks.

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2022
• Primary Completion (Actual): April 8, 2024
• Study Completion (Actual): July 8, 2024

Study Registration Dates

• First Submitted: November 11, 2021
• First Submitted That Met QC Criteria: November 11, 2021
• First Posted (Actual): November 23, 2021

Study Record Updates

• Last Update Posted (Estimated): August 27, 2025
• Last Update Submitted That Met QC Criteria: August 8, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Purines; Quinazolines; Linagliptin; empagliflozin
• Other Study ID Numbers: 1275-0028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

The data shared are the raw clinical study data sets.

• IPD Sharing Time Frame: After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
• IPD Sharing Access Criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No