Trial Outcomes & Findings for Esgliteo Post Marketing Surveillance (PMS) in Korean Patients With Type 2 Diabetes Mellitus (NCT NCT05130463)
NCT ID: NCT05130463
Last Updated: 2025-08-27
Results Overview
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.
COMPLETED
1053 participants
From first trial drug administration up to 24 weeks.
2025-08-27
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
1053
|
|
Overall Study
COMPLETED
|
616
|
|
Overall Study
NOT COMPLETED
|
437
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Unspecified reasons
|
2
|
|
Overall Study
off-label indication dose
|
435
|
Baseline Characteristics
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.
Baseline characteristics by cohort
| Measure |
Patients Diagnosed With Type 2 Diabetes Mellitus
n=616 Participants
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.
|
|---|---|
|
Age, Continuous
|
58.7 years
STANDARD_DEVIATION 12.40 • n=616 Participants
|
|
Sex: Female, Male
Female
|
230 Participants
n=616 Participants
|
|
Sex: Female, Male
Male
|
386 Participants
n=616 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=616 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
616 Participants
n=616 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=616 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=616 Participants
|
|
Race (NIH/OMB)
Asian
|
616 Participants
n=616 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=616 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=616 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=616 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=616 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=616 Participants
|
|
Baseline glycosylated hemoglobin (HbA1c)
|
7.32 Percentage
STANDARD_DEVIATION 1.191 • n=342 Participants • 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.
|
PRIMARY outcome
Timeframe: From first trial drug administration up to 24 weeks.Population: 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.
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.
Outcome measures
| Measure |
Patients Diagnosed With Type 2 Diabetes
n=616 Participants
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.
|
|---|---|
|
All Reported Adverse Events Collected From Subjects Taking at Least One Dose of ESGLITEO®
|
26 Number of events
|
PRIMARY outcome
Timeframe: From the first trial drug administration up to 12 weeks.Population: Effectiveness Set: Participants who signed the data release consent form, followed the study schedule, took Esgliteo at least once, and were evaluated for effectiveness.
The mean change from baseline in glycosylated hemoglobin (HbA1c) after 12 weeks of treatment is presented.
Outcome measures
| Measure |
Patients Diagnosed With Type 2 Diabetes
n=303 Participants
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.
|
|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c) After 12 Weeks of Treatment
|
-0.21 Percentage
Standard Deviation 1.126
|
PRIMARY outcome
Timeframe: From the first trial drug administration up to 24 weeks.Population: Effectiveness Set: Participants who signed the data release consent form, followed the study schedule, took Esgliteo at least once, and were evaluated for effectiveness.
The mean change from baseline in glycosylated hemoglobin (HbA1c) after 24 weeks of treatment is presented.
Outcome measures
| Measure |
Patients Diagnosed With Type 2 Diabetes
n=139 Participants
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.
|
|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c) After 24 Weeks of Treatment
|
-0.27 Percentage
Standard Deviation 0.983
|
SECONDARY outcome
Timeframe: From the first trial drug administration up to 12 weeks.Population: Effectiveness Set: Participants who signed the data release consent form, followed the study schedule, took Esgliteo at least once, and were evaluated for effectiveness.
The percentage of patients whose glycosylated hemoglobin (HbA1c) levels dropped below 7% at 12 weeks following trial drug administration are presented.
Outcome measures
| Measure |
Patients Diagnosed With Type 2 Diabetes
n=303 Participants
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.
|
|---|---|
|
Percentage of Participants With HbA1c Reaching Less Than 7% From Baseline (Target Effectiveness Response Rate) After 12 Weeks of Treatment
|
49.50 Percentage of participants
Interval 43.74 to 55.28
|
SECONDARY outcome
Timeframe: From the first trial drug administration up to 24 weeks.Population: Effectiveness Set: Participants who signed the data release consent form, followed the study schedule, took Esgliteo at least once, and were evaluated for effectiveness.
The percentage of patients whose glycosylated hemoglobin (HbA1c) levels dropped below 7% at 24 weeks following trial drug administration are presented.
Outcome measures
| Measure |
Patients Diagnosed With Type 2 Diabetes
n=139 Participants
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.
|
|---|---|
|
Percentage of Participants With HbA1c Reaching Less Than 7% From Baseline (Target Effectiveness Response Rate) After 24 Weeks of Treatment
|
53.24 Percentage of participants
Interval 44.59 to 61.74
|
SECONDARY outcome
Timeframe: From the first trial drug administration up to 12 weeks.Population: Effectiveness Set: Participants who signed the data release consent form, followed the study schedule, took Esgliteo at least once, and were evaluated for effectiveness.
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®.
Outcome measures
| Measure |
Patients Diagnosed With Type 2 Diabetes
n=303 Participants
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.
|
|---|---|
|
Percentage of Participants With Occurrence of Relative Effectiveness Response After 12 Weeks of Treatment
|
29.37 Percentage of participants
Interval 24.3 to 34.85
|
SECONDARY outcome
Timeframe: From the first trial drug administration up to 24 weeks.Population: Effectiveness Set: Participants who signed the data release consent form, followed the study schedule, took Esgliteo at least once, and were evaluated for effectiveness.
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®.
Outcome measures
| Measure |
Patients Diagnosed With Type 2 Diabetes
n=139 Participants
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.
|
|---|---|
|
Percentage of Participants With Occurrence of Relative Effectiveness Response After 24 Weeks of Treatment
|
38.85 Percentage of participants
Interval 30.71 to 47.48
|
SECONDARY outcome
Timeframe: From the first trial drug administration up to 12 weeks.Population: Effectiveness Set: Participants who signed the data release consent form, followed the study schedule, took Esgliteo at least once, and were evaluated for effectiveness.
Change from baseline in fasting plasma glucose (FPG) of participants after 12 weeks of treatment is presented.
Outcome measures
| Measure |
Patients Diagnosed With Type 2 Diabetes
n=302 Participants
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.
|
|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG) After 12 Weeks of Treatment
|
-10.8 milligrams per deciliter (mg/dL)
Standard Deviation 54.90
|
SECONDARY outcome
Timeframe: From the first trial drug administration up to 24 weeks.Population: Effectiveness Set: Participants who signed the data release consent form, followed the study schedule, took Esgliteo at least once, and were evaluated for effectiveness.
Change from baseline in fasting plasma glucose (FPG) of participants after 24 weeks of treatment is presented.
Outcome measures
| Measure |
Patients Diagnosed With Type 2 Diabetes
n=154 Participants
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.
|
|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks of Treatment
|
-12.3 milligrams per deciliter (mg/dL)
Standard Deviation 55.76
|
SECONDARY outcome
Timeframe: From the first trial drug administration up to 12 weeks.Population: Effectiveness Set: Participants who signed the data release consent form, followed the study schedule, took Esgliteo at least once, and were evaluated for effectiveness.
Change from baseline in body weight of participants after 12 weeks of treatment is presented.
Outcome measures
| Measure |
Patients Diagnosed With Type 2 Diabetes
n=107 Participants
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.
|
|---|---|
|
Change From Baseline in Body Weight After 12 Weeks of Treatment
|
-0.72 Kilogram (kg)
Standard Deviation 5.583
|
SECONDARY outcome
Timeframe: From the first trial drug administration up to 24 weeks.Population: Effectiveness Set: Participants who signed the data release consent form, followed the study schedule, took Esgliteo at least once, and were evaluated for effectiveness.
Change from baseline in body weight of participants after 24 weeks of treatment is presented.
Outcome measures
| Measure |
Patients Diagnosed With Type 2 Diabetes
n=93 Participants
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.
|
|---|---|
|
Change From Baseline in Body Weight After 24 Weeks of Treatment
|
-1.27 Kilogram (kg)
Standard Deviation 3.204
|
SECONDARY outcome
Timeframe: From the first trial drug administration up to 12 weeks.Population: Effectiveness Set: Participants who signed the data release consent form, followed the study schedule, took Esgliteo at least once, and were evaluated for effectiveness.
Mean change from baseline in blood pressure (systolic blood pressure \[SBP\], diastolic blood pressure \[DBP\]) of participants after 12 weeks of treatment is presented.
Outcome measures
| Measure |
Patients Diagnosed With Type 2 Diabetes
n=241 Participants
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.
|
|---|---|
|
Change From Baseline in Blood Pressure (Systolic Blood Pressure [SBP], Diastolic Blood Pressure [DBP]) After 12 Weeks of Treatment
Change from baseline in systolic blood pressure after 12 weeks of treatment
|
-2.8 Millimeters of mercury (mmHg)
Standard Deviation 13.77
|
|
Change From Baseline in Blood Pressure (Systolic Blood Pressure [SBP], Diastolic Blood Pressure [DBP]) After 12 Weeks of Treatment
Change from baseline in diastolic blood pressure after 12 weeks of treatment
|
-1.6 Millimeters of mercury (mmHg)
Standard Deviation 9.91
|
SECONDARY outcome
Timeframe: From the first trial drug administration up to 24 weeks.Population: Effectiveness Set: Participants who signed the data release consent form, followed the study schedule, took Esgliteo at least once, and were evaluated for effectiveness.
Mean change from baseline in blood pressure (systolic blood pressure \[SBP\], diastolic blood pressure \[DBP\]) of participants after 24 weeks of treatment is presented.
Outcome measures
| Measure |
Patients Diagnosed With Type 2 Diabetes
n=134 Participants
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.
|
|---|---|
|
Change From Baseline in Blood Pressure (Systolic Blood Pressure [SBP], Diastolic Blood Pressure [DBP]) After 24 Weeks of Treatment
Change from baseline in systolic blood pressure after 24 weeks of treatment
|
-0.4 Millimeters of mercury (mmHg)
Standard Deviation 16.59
|
|
Change From Baseline in Blood Pressure (Systolic Blood Pressure [SBP], Diastolic Blood Pressure [DBP]) After 24 Weeks of Treatment
Change from baseline in diastolic blood pressure after 24 weeks of treatment
|
-0.6 Millimeters of mercury (mmHg)
Standard Deviation 11.01
|
Adverse Events
Patients Diagnosed With Type 2 Diabetes
Serious adverse events
| Measure |
Patients Diagnosed With Type 2 Diabetes
n=616 participants at risk
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.
|
|---|---|
|
Endocrine disorders
Adrenal insufficiency
|
0.16%
1/616 • 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.
|
|
Vascular disorders
Aortic thrombosis
|
0.16%
1/616 • 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.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.16%
1/616 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.16%
1/616 • 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.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER