Diabetes Mellitus, Type 2
Conditions
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.
Interventions
Participants received Empagliflozin 10mg or 25mg and Linagliptin 5mg (Fixed Dose) Film-coated tablets orally once daily with or without food.
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Glycosylated Hemoglobin (HbA1c) After 24 Weeks of Treatment | 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. |
| All Reported Adverse Events Collected From Subjects Taking at Least One Dose of ESGLITEO® | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Occurrence of Relative Effectiveness Response After 24 Weeks of Treatment | From the first trial drug administration up to 24 weeks. | 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®. |
| Change From Baseline in Fasting Plasma Glucose (FPG) After 12 Weeks of Treatment | From the first trial drug administration up to 12 weeks. | Change from baseline in fasting plasma glucose (FPG) of participants after 12 weeks of treatment is presented. |
| Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks of Treatment | From the first trial drug administration up to 24 weeks. | Change from baseline in fasting plasma glucose (FPG) of participants after 24 weeks of treatment is presented. |
| 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. | The percentage of patients whose glycosylated hemoglobin (HbA1c) levels dropped below 7% at 12 weeks following trial drug administration are presented. |
| Change From Baseline in Body Weight After 24 Weeks of Treatment | From the first trial drug administration up to 24 weeks. | Change from baseline in body weight of participants after 24 weeks of treatment is presented. |
| Change From Baseline in Blood Pressure (Systolic Blood Pressure [SBP], Diastolic Blood Pressure [DBP]) After 12 Weeks of Treatment | From the first trial drug administration up to 12 weeks. | Mean change from baseline in blood pressure (systolic blood pressure \[SBP\], diastolic blood pressure \[DBP\]) of participants after 12 weeks of treatment is presented. |
| Change From Baseline in Blood Pressure (Systolic Blood Pressure [SBP], Diastolic Blood Pressure [DBP]) After 24 Weeks of Treatment | From the first trial drug administration up to 24 weeks. | Mean change from baseline in blood pressure (systolic blood pressure \[SBP\], diastolic blood pressure \[DBP\]) of participants after 24 weeks of treatment is presented. |
| Change From Baseline in Body Weight After 12 Weeks of Treatment | From the first trial drug administration up to 12 weeks. | Change from baseline in body weight of participants after 12 weeks of treatment is presented. |
| 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. | The percentage of patients whose glycosylated hemoglobin (HbA1c) levels dropped below 7% at 24 weeks following trial drug administration are presented. |
| Percentage of Participants With Occurrence of Relative Effectiveness Response After 12 Weeks of Treatment | From the first trial drug administration up to 12 weeks. | 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®. |
Countries
South Korea
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 616 |
| Total | 616 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | off-label indication dose | 435 |
| Overall Study | Unspecified reasons | 2 |
Baseline characteristics
| Characteristic | Patients Diagnosed With Type 2 Diabetes Mellitus |
|---|---|
| Age, Continuous | 58.7 years STANDARD_DEVIATION 12.4 |
| Baseline glycosylated hemoglobin (HbA1c) | 7.32 Percentage STANDARD_DEVIATION 1.191 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 616 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 616 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 230 Participants |
| Sex: Female, Male Male | 386 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 616 |
| other Total, other adverse events | 0 / 616 |
| serious Total, serious adverse events | 3 / 616 |
Outcome results
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients Diagnosed With Type 2 Diabetes | All Reported Adverse Events Collected From Subjects Taking at Least One Dose of ESGLITEO® | 26 Number of events |
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients Diagnosed With Type 2 Diabetes | Change From Baseline in Glycosylated Hemoglobin (HbA1c) After 12 Weeks of Treatment | -0.21 Percentage | Standard Deviation 1.126 |
p-value: 0.0011t-test, 2 sided
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients Diagnosed With Type 2 Diabetes | Change From Baseline in Glycosylated Hemoglobin (HbA1c) After 24 Weeks of Treatment | -0.27 Percentage | Standard Deviation 0.983 |
p-value: 0.0014t-test, 2 sided
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients Diagnosed With Type 2 Diabetes | 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 |
| Patients Diagnosed With Type 2 Diabetes | 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 |
Comparison: SBP at baseline vs SBP after 12 weeks of treatment.p-value: 0.002t-test, 2 sided
Comparison: DBP at baseline vs DBP after 12 weeks of treatment.p-value: 0.0132t-test, 2 sided
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients Diagnosed With Type 2 Diabetes | 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 |
| Patients Diagnosed With Type 2 Diabetes | 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 |
Comparison: SBP at baseline vs SBP after 24 weeks of treatment.p-value: 0.7591t-test, 2 sided
Comparison: DBP at baseline vs DBP after 24 weeks of treatment.p-value: 0.5161t-test, 2 sided
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients Diagnosed With Type 2 Diabetes | Change From Baseline in Body Weight After 12 Weeks of Treatment | -0.72 Kilogram (kg) | Standard Deviation 5.583 |
Comparison: Body weight at baseline vs Body weight after 12 weeks of treatment.p-value: 0.1867t-test, 2 sided
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients Diagnosed With Type 2 Diabetes | Change From Baseline in Body Weight After 24 Weeks of Treatment | -1.27 Kilogram (kg) | Standard Deviation 3.204 |
Comparison: Body weight at baseline vs Body weight after 24 weeks of treatment.p-value: 0.0003t-test, 2 sided
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients Diagnosed With Type 2 Diabetes | Change From Baseline in Fasting Plasma Glucose (FPG) After 12 Weeks of Treatment | -10.8 milligrams per deciliter (mg/dL) | Standard Deviation 54.9 |
Comparison: FPG at baseline vs FPG after 12 weeks of treatment.p-value: 0.0008t-test, 2 sided
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients Diagnosed With Type 2 Diabetes | Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks of Treatment | -12.3 milligrams per deciliter (mg/dL) | Standard Deviation 55.76 |
Comparison: FPG at baseline vs FPG after 24 weeks of treatment.p-value: 0.0068t-test, 2 sided
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients Diagnosed With Type 2 Diabetes | 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 |
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients Diagnosed With Type 2 Diabetes | 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 |
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®.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients Diagnosed With Type 2 Diabetes | Percentage of Participants With Occurrence of Relative Effectiveness Response After 12 Weeks of Treatment | 29.37 Percentage of participants |
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®.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients Diagnosed With Type 2 Diabetes | Percentage of Participants With Occurrence of Relative Effectiveness Response After 24 Weeks of Treatment | 38.85 Percentage of participants |