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

December 19, 2023 updated by: Boehringer Ingelheim

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

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

684

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients diagnosed with type 2 diabetes mellitus
Drug: empagliflozin/linagliptin
tablet
Other Names:
  • Esgliteo®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurence of adverse events
Time Frame: 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)
up to 24 weeks
Change from baseline in HbA1c after 12 weeks of treatment
Time Frame: at baseline, at week 12
at baseline, at week 12
Change from baseline in HbA1c after 24 weeks of treatment
Time Frame: at baseline, at week 24
at baseline, at week 24

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 22, 2022

Primary Completion (Estimated)

April 30, 2024

Study Completion (Estimated)

April 30, 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)

December 20, 2023

Last Update Submitted That Met QC Criteria

December 19, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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