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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empagliflozin/Linagliptin | Drug | Participants received Empagliflozin 10mg or 25mg and Linagliptin 5mg (Fixed Dose) Film-coated tablets orally once daily with or without food. |
|
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed with type 2 diabetes mellitus in Korea.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cheonan Chungmu Hospital | Cheonan-si | Chungcheongnam-do | 31181 | South Korea | ||
| Woori-hospital |
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| Label | URL |
|---|---|
| Related Info | View source |
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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.
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.
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'.
Patients diagnosed with type 2 diabetes mellitus in Korea were included in this study. ESGLITEO® is administered as an adjunct to diet and exercise therapy to improve glycaemic control in these patients. This non-interventional study (NIS) follows a single-arm design with ESGLITEO®, prescribed according to the local label and at the discretion of the treating physician.
This non-interventional, multi-centre, single-country study focuses on providing additional safety and effectiveness information for Korean patients with type 2 diabetes mellitus in routine clinical settings. It aims to monitor the safety and effectiveness of ESGLITEO® (Empagliflozin/Linagliptin, 10/5 mg, 25/5 mg) in these patients as part of post-marketing surveillance.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 28, 2022 | May 21, 2025 |
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| 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. |
| Bucheon-si |
| Gyeonggi-do |
| 14706 |
| South Korea |
| Seo Jung Hwa Internal medicine | Gwangmyeong | Gyeonggi-do | 14248 | South Korea |
| Samsung Internal medicine | Hanam | Gyeonggi-do | 12927 | South Korea |
| Brrunmadi Orthopedics | Seongnam-si | Gyeonggi-do | 13182 | South Korea |
| ST.Mary's Will Hospital | Seongnam-si | Gyeonggi-do | 13313 | South Korea |
| 21Chospital | Seongnam-si | Gyeonggi-do | 13577 | South Korea |
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 13620 | South Korea |
| Dr.Yoon's Clinic | Gyeongsan-si | Gyeongsangbuk-do | 38657 | South Korea |
| Yeongju gidok hospital | Yeongju | Gyeongsangbuk-do | 36096 | South Korea |
| Seoul NIM Clinic | Changwon-si, | Gyeongsangnam-do | 51595 | South Korea |
| Choi Bongki Internal Medicine | Changwon-si | Gyeongsangnam-do | 51449 | South Korea |
| Gyeongsang National Univ. Changwon Hospital | Changwon-si | Gyeongsangnam-do | 51472 | South Korea |
| Chonnam National Univ. Hwasun Hospital | Hwasun-gun | Jeollanam-do | 58128 | South Korea |
| Park Chang Hyun Clinic | Mokpo-si | Jeollanam-do | 58640 | South Korea |
| Mokpo Gospel Internal Medicine Clinic | Mokpo-si | Jeollanam-do | 58664 | South Korea |
| Park Il Jong Clinic | Mokpo-si | Jeollanam-do | 58707 | South Korea |
| Yeosu Jeil Hospital | Yeosu | Jeollanam-do | 59677 | South Korea |
| Yonsei Clinic | Busan | 46555 | South Korea |
| MyungJi Medical Center | Busan | 46726 | South Korea |
| Choi Won Rak Clinic | Busan | 49374 | South Korea |
| Daejeon Endo Internal Medicine | Daejeon | 35220 | South Korea |
| Good Morning Interanl medicine | Gwangju | 61675 | South Korea |
| Park Clinic | Gwangju | 62258 | South Korea |
| IBS Medical Clinic | Incheon | 22006 | South Korea |
| Dream Internal Medicine Clinic | Jeju City | 63083 | South Korea |
| D&F Hospital | Seoul | 02089 | South Korea |
| Kyung Hee University Medical Center | Seoul | 02447 | South Korea |
| Yonsei Checkup Clinic | Seoul | 05719 | South Korea |
| CBY Endocrine & Internal Medicine | Seoul | 08783 | South Korea |
| COMPLETED |
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| NOT COMPLETED |
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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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Participants Whose CRF Was Retrieved: This includes participants who signed the data release consent form, participated in the study, and took Esgliteo at least once. | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | Participants Whose CRF Was Retrieved: This includes participants who signed the data release consent form, participated in the study, and took Esgliteo at least once. | Count of Participants | Participants |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Participants Whose CRF Was Retrieved: This includes participants who signed the data release consent form, participated in the study, and took Esgliteo at least once. | Count of Participants | Participants |
| |||||||||||||||
| Race (NIH/OMB) | Participants Whose CRF Was Retrieved: This includes participants who signed the data release consent form, participated in the study, and took Esgliteo at least once. | Count of Participants | Participants |
| |||||||||||||||
| Baseline glycosylated hemoglobin (HbA1c) | Baseline HbA1c values for participants who took Esgliteo at least once, and were evaluated for the effectiveness is presented. | These cases include those who signed the data release consent form to participate in this study as subject, visited as per the study schedule, took Esgliteo at least once, and were evaluated for the effectiveness. | Mean | Standard Deviation | Percentage |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Number | Number of events | From first trial drug administration up to 24 weeks. |
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| ||||||||||||||||||||||||||
| Primary | 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. | Effectiveness Set: Participants who signed the data release consent form, followed the study schedule, took Esgliteo at least once, and were evaluated for effectiveness. | Posted | Mean | Standard Deviation | Percentage | From the first trial drug administration up to 12 weeks. |
|
| ||||||||||||||||||||||||||
| Primary | 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. | Effectiveness Set: Participants who signed the data release consent form, followed the study schedule, took Esgliteo at least once, and were evaluated for effectiveness. | Posted | Mean | Standard Deviation | Percentage | From the first trial drug administration up to 24 weeks. |
|
| ||||||||||||||||||||||||||
| Secondary | 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. | Effectiveness Set: Participants who signed the data release consent form, followed the study schedule, took Esgliteo at least once, and were evaluated for effectiveness. | Posted | Number | 95% Confidence Interval | Percentage of participants | From the first trial drug administration up to 12 weeks. |
|
| ||||||||||||||||||||||||||
| Secondary | 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. | Effectiveness Set: Participants who signed the data release consent form, followed the study schedule, took Esgliteo at least once, and were evaluated for effectiveness. | Posted | Number | 95% Confidence Interval | Percentage of participants | From the first trial drug administration up to 24 weeks. |
|
| ||||||||||||||||||||||||||
| Secondary | 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®. | Effectiveness Set: Participants who signed the data release consent form, followed the study schedule, took Esgliteo at least once, and were evaluated for effectiveness. | Posted | Number | 95% Confidence Interval | Percentage of participants | From the first trial drug administration up to 12 weeks. |
|
| ||||||||||||||||||||||||||
| Secondary | 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®. | Effectiveness Set: Participants who signed the data release consent form, followed the study schedule, took Esgliteo at least once, and were evaluated for effectiveness. | Posted | Number | 95% Confidence Interval | Percentage of participants | From the first trial drug administration up to 24 weeks. |
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| Secondary | 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. | Effectiveness Set: Participants who signed the data release consent form, followed the study schedule, took Esgliteo at least once, and were evaluated for effectiveness. | Posted | Mean | Standard Deviation | milligrams per deciliter (mg/dL) | From the first trial drug administration up to 12 weeks. |
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| Secondary | 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. | Effectiveness Set: Participants who signed the data release consent form, followed the study schedule, took Esgliteo at least once, and were evaluated for effectiveness. | Posted | Mean | Standard Deviation | milligrams per deciliter (mg/dL) | From the first trial drug administration up to 24 weeks. |
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| Secondary | 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. | Effectiveness Set: Participants who signed the data release consent form, followed the study schedule, took Esgliteo at least once, and were evaluated for effectiveness. | Posted | Mean | Standard Deviation | Kilogram (kg) | From the first trial drug administration up to 12 weeks. |
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| Secondary | 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. | Effectiveness Set: Participants who signed the data release consent form, followed the study schedule, took Esgliteo at least once, and were evaluated for effectiveness. | Posted | Mean | Standard Deviation | Kilogram (kg) | From the first trial drug administration up to 24 weeks. |
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| Secondary | 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. | Effectiveness Set: Participants who signed the data release consent form, followed the study schedule, took Esgliteo at least once, and were evaluated for effectiveness. | Posted | Mean | Standard Deviation | Millimeters of mercury (mmHg) | From the first trial drug administration up to 12 weeks. |
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| Secondary | 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. | Effectiveness Set: Participants who signed the data release consent form, followed the study schedule, took Esgliteo at least once, and were evaluated for effectiveness. | Posted | Mean | Standard Deviation | Millimeters of mercury (mmHg) | From the first trial drug administration up to 24 weeks. |
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AE and All-cause mortality collection period: From first Esgliteo administration up to 24 weeks.
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients Diagnosed With Type 2 Diabetes | 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. | 0 | 616 | 3 | 616 | 0 | 616 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adrenal insufficiency | Endocrine disorders | MedDRA 26.0 | Systematic Assessment |
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| Aortic thrombosis | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
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| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
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Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 018002430127 | clintriage.rdg@boehringer-ingelheim.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 19, 2023 | May 21, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C570240 | empagliflozin |
| D000069476 | Linagliptin |
| ID | Term |
|---|---|
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011799 | Quinazolines |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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