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

An observational study of Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 30 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 19 years and older
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: Empagliflozin/Linagliptin
Type of treatment: Pill or oral medicine
How many people: 1,053 participants
Where: 30 sitesSouth Korea
Study dates: 22 Mar 2022to 8 Jul 2024
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients diagnosed with type 2 diabetes mellitus in Korea.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

30 sites in 1 country.

City, postcode or hospital

30 sites in 1 country

South Korea30 sites

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

Other trials in South Korea

About this study

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

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
Being tested: Empagliflozin/Linagliptin
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT05130463
Study group	Role	What they receive
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. Receives: Drug: Empagliflozin/Linagliptin

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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
The percentage of patients whose glycosylated hemoglobin (HbA1c) levels dropped below 7% at 12 weeks following trial drug administration are presented.
Measured: 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.
Measured: 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®.
Measured: 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®.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From the first trial drug administration up to 24 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Mar 20228 Jul 2024

First posted23 Nov 2021
Study start22 Mar 2022
Primary completion8 Apr 2024
Study completion8 Jul 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 1,053 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05130463
Sponsor's protocol ID: 1275-0028
Status last verified: Aug 2025
First submitted: 11 Nov 2021
Last updated: 27 Aug 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diabetes Mellitus, Type 2 trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05130463
Acronym / sponsor ID: 1275-0028
Conditions: Diabetes Mellitus, Type 2
Study type: Observational
Recruitment status: Completed
Enrolment: 1,053 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 22 Mar 2022 (actual)
Primary completion: 8 Apr 2024 (actual)
Study completion: 8 Jul 2024 (actual)
First posted: 23 Nov 2021 (actual)
Results: Posted 27 Aug 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Patients diagnosed with type 2 diabetes mellitus	–	Drug: Empagliflozin/LinagliptinPatients 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.

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients diagnosed with type 2 diabetes mellitus in Korea.

Key inclusion criteria (3 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Empagliflozin/LinagliptinAlso: Esgliteo®Participants received Empagliflozin 10mg or 25mg and Linagliptin 5mg (Fixed Dose) Film-coated tablets orally once daily with or without food.	Drug	Patients diagnosed with type 2 diabetes mellitus

Primary outcome

All Reported Adverse Events Collected From Subjects Taking at Least One Dose of ESGLITEO®
Time frame: From first trial drug administration up to 24 weeks.
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.
Change From Baseline in Glycosylated Hemoglobin (HbA1c) After 12 Weeks of Treatment
Time frame: From the first trial drug administration up to 12 weeks.
The mean change from baseline in glycosylated hemoglobin (HbA1c) after 12 weeks of treatment is presented.
Change From Baseline in Glycosylated Hemoglobin (HbA1c) After 24 Weeks of Treatment
Time frame: From the first trial drug administration up to 24 weeks.
The mean change from baseline in glycosylated hemoglobin (HbA1c) after 24 weeks of treatment is presented.

10 secondary outcomes

Percentage of Participants With HbA1c Reaching Less Than 7% From Baseline (Target Effectiveness Response Rate) After 12 Weeks of Treatment
Time frame: 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
Time frame: From the first trial drug administration up to 24 weeks.
Percentage of Participants With Occurrence of Relative Effectiveness Response After 12 Weeks of Treatment
Time frame: From the first trial drug administration up to 12 weeks.
Percentage of Participants With Occurrence of Relative Effectiveness Response After 24 Weeks of Treatment
Time frame: From the first trial drug administration up to 24 weeks.
Change From Baseline in Fasting Plasma Glucose (FPG) After 12 Weeks of Treatment
Time frame: From the first trial drug administration up to 12 weeks.
Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks of Treatment
Time frame: From the first trial drug administration up to 24 weeks.
Change From Baseline in Body Weight After 12 Weeks of Treatment
Time frame: From the first trial drug administration up to 12 weeks.
Change From Baseline in Body Weight After 24 Weeks of Treatment
Time frame: 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
Time frame: 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
Time frame: From the first trial drug administration up to 24 weeks.

Results and safety

Results posted to the registry on 27 Aug 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patients Diagnosed With Type 2 Diabetes Mellitus	1,053	616

Primary outcome: All Reported Adverse Events Collected From Subjects Taking at Least One Dose of ESGLITEO®

Time frame: From first trial drug administration up to 24 weeks.. Number. Unit: Number of events

Measure	Patients Diagnosed With Type 2 Diabetes n = 616
Value	26

Population analysed: Safety Set: This set includes participants who signed the data release consent form, took Esgliteo at least once, and were followed up by a physician at least once.

Primary outcome: Change From Baseline in Glycosylated Hemoglobin (HbA1c) After 12 Weeks of Treatment

Time frame: From the first trial drug administration up to 12 weeks.. Mean (Standard Deviation). Unit: Percentage

Measure	Patients Diagnosed With Type 2 Diabetes n = 303
Value	-0.21 (1.126)

Patients Diagnosed With Type 2 Diabetes: p = 0.0011, t-test, 2 sided

Population analysed: Effectiveness Set: Participants who signed the data release consent form, followed the study schedule, took Esgliteo at least once, and were evaluated for effectiveness.

Primary outcome: Change From Baseline in Glycosylated Hemoglobin (HbA1c) After 24 Weeks of Treatment

Time frame: From the first trial drug administration up to 24 weeks.. Mean (Standard Deviation). Unit: Percentage

Measure	Patients Diagnosed With Type 2 Diabetes n = 139
Value	-0.27 (0.983)

Patients Diagnosed With Type 2 Diabetes: p = 0.0014, t-test, 2 sided

Population analysed: Effectiveness Set: Participants who signed the data release consent form, followed the study schedule, took Esgliteo at least once, and were evaluated for effectiveness.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: AE and All-cause mortality collection period: From first Esgliteo administration up to 24 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patients Diagnosed With Type 2 Diabetes	3 of 616 (0.5%)	0 of 616 (0%)	0 of 616

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

30 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 30 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All Reported Adverse Events Collected From Subjects Taking at Least One Dose of ESGLITEO® (time frame: From first trial drug administration up to 24 weeks.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05130463.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2025.