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

NCT05130463 | Completed Results

• 1 other identifier: 1275-0028
• Study Type: observational
• Target: 1,053
• Locations: 1 country
• Sites: 30

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (10)

• Percentage of Participants With HbA1c Reaching Less Than 7% From Baseline (Target Effectiveness Response Rate) After 12 Weeks of Treatment

  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

  From the first trial drug administration up to 24 weeks.

• Percentage of Participants With Occurrence of Relative Effectiveness Response After 12 Weeks of Treatment

  From the first trial drug administration up to 12 weeks.

• Percentage of Participants With Occurrence of Relative Effectiveness Response After 24 Weeks of Treatment

  From the first trial drug administration up to 24 weeks.

• Change From Baseline in Fasting Plasma Glucose (FPG) After 12 Weeks of Treatment

  From the first trial drug administration up to 12 weeks.

Study Arms (1)

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

Interventions

Empagliflozin/Linagliptin DRUG

Participants received Empagliflozin 10mg or 25mg and Linagliptin 5mg (Fixed Dose) Film-coated tablets orally once daily with or without food.

Also known as: Esgliteo®

Patients diagnosed with type 2 diabetes mellitus

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients diagnosed with type 2 diabetes mellitus in Korea.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (30)

Cheonan Chungmu Hospital

Cheonan-si, Chungcheongnam-do, 31181, South Korea

Location

Woori-hospital

Bucheon-si, Gyeonggi-do, 14706, South Korea

Location

Seo Jung Hwa Internal medicine

Gwangmyeong, Gyeonggi-do, 14248, South Korea

Location

Samsung Internal medicine

Hanam, Gyeonggi-do, 12927, South Korea

Location

Brrunmadi Orthopedics

Seongnam-si, Gyeonggi-do, 13182, South Korea

Location

ST.Mary's Will Hospital

Seongnam-si, Gyeonggi-do, 13313, South Korea

Location

21Chospital

Seongnam-si, Gyeonggi-do, 13577, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

Dr.Yoon's Clinic

Gyeongsan-si, Gyeongsangbuk-do, 38657, South Korea

Location

Yeongju gidok hospital

Yeongju, Gyeongsangbuk-do, 36096, South Korea

Location

Seoul NIM Clinic

Changwon-si,, Gyeongsangnam-do, 51595, South Korea

Location

Choi Bongki Internal Medicine

Changwon-si, Gyeongsangnam-do, 51449, South Korea

Location

Gyeongsang National Univ. Changwon Hospital

Changwon-si, Gyeongsangnam-do, 51472, South Korea

Location

Chonnam National Univ. Hwasun Hospital

Hwasun-gun, Jeollanam-do, 58128, South Korea

Location

Park Chang Hyun Clinic

Mokpo-si, Jeollanam-do, 58640, South Korea

Location

Mokpo Gospel Internal Medicine Clinic

Mokpo-si, Jeollanam-do, 58664, South Korea

Location

Park Il Jong Clinic

Mokpo-si, Jeollanam-do, 58707, South Korea

Location

Yeosu Jeil Hospital

Yeosu, Jeollanam-do, 59677, South Korea

Location

Yonsei Clinic

Busan, 46555, South Korea

Location

MyungJi Medical Center

Busan, 46726, South Korea

Location

Choi Won Rak Clinic

Busan, 49374, South Korea

Location

Daejeon Endo Internal Medicine

Daejeon, 35220, South Korea

Location

Good Morning Interanl medicine

Gwangju, 61675, South Korea

Location

Park Clinic

Gwangju, 62258, South Korea

Location

IBS Medical Clinic

Incheon, 22006, South Korea

Location

Dream Internal Medicine Clinic

Jeju City, 63083, South Korea

Location

D&F Hospital

Seoul, 02089, South Korea

Location

Kyung Hee University Medical Center

Seoul, 02447, South Korea

Location

Yonsei Checkup Clinic

Seoul, 05719, South Korea

Location

CBY Endocrine & Internal Medicine

Seoul, 08783, South Korea

Location

Related Links

• Related Info

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

empagliflozin; Linagliptin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinazolines

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

018002430127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2021
• First Posted: November 23, 2021
• Study Start: March 22, 2022
• Primary Completion: April 8, 2024
• Study Completion: July 8, 2024
• Last Updated: August 27, 2025
• Results First Posted: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.
• 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'.

Locations

KR (30)