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

• Empagliflozin/Linagliptin (Drug), also known as Esgliteo®: Participants received Empagliflozin 10mg or 25mg and Linagliptin 5mg (Fixed Dose) Film-coated tablets orally once daily with or without food.

Primary outcomes

• 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.
• 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.

Secondary outcomes

• 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.
• 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®.
• 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.
• 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.
• 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.

Sex: All, ages: 19 Years to any

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

Participant flow

Outcome results

• All Reported Adverse Events Collected From Subjects Taking at Least One Dose of ESGLITEO® (Primary), Number, Number of events: Patients Diagnosed With Type 2 Diabetes 26
• Change From Baseline in Glycosylated Hemoglobin (HbA1c) After 12 Weeks of Treatment (Primary), Mean, Percentage: Patients Diagnosed With Type 2 Diabetes -0.21 +/- 1.126 (p 0.0011)
• Change From Baseline in Glycosylated Hemoglobin (HbA1c) After 24 Weeks of Treatment (Primary), Mean, Percentage: Patients Diagnosed With Type 2 Diabetes -0.27 +/- 0.983 (p 0.0014)
• Percentage of Participants With HbA1c Reaching Less Than 7% From Baseline (Target Effectiveness Response Rate) After 12 Weeks of Treatment (Secondary), Number, Percentage of participants: Patients Diagnosed With Type 2 Diabetes 49.50 (43.74 to 55.28)
• Percentage of Participants With HbA1c Reaching Less Than 7% From Baseline (Target Effectiveness Response Rate) After 24 Weeks of Treatment (Secondary), Number, Percentage of participants: Patients Diagnosed With Type 2 Diabetes 53.24 (44.59 to 61.74)
• Percentage of Participants With Occurrence of Relative Effectiveness Response After 12 Weeks of Treatment (Secondary), Number, Percentage of participants: Patients Diagnosed With Type 2 Diabetes 29.37 (24.30 to 34.85)
• Percentage of Participants With Occurrence of Relative Effectiveness Response After 24 Weeks of Treatment (Secondary), Number, Percentage of participants: Patients Diagnosed With Type 2 Diabetes 38.85 (30.71 to 47.48)
• Change From Baseline in Fasting Plasma Glucose (FPG) After 12 Weeks of Treatment (Secondary), Mean, milligrams per deciliter (mg/dL): Patients Diagnosed With Type 2 Diabetes -10.8 +/- 54.90 (p 0.0008)
• Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks of Treatment (Secondary), Mean, milligrams per deciliter (mg/dL): Patients Diagnosed With Type 2 Diabetes -12.3 +/- 55.76 (p 0.0068)
• Change From Baseline in Body Weight After 12 Weeks of Treatment (Secondary), Mean, Kilogram (kg): Patients Diagnosed With Type 2 Diabetes -0.72 +/- 5.583 (p 0.1867)
• Change From Baseline in Body Weight After 24 Weeks of Treatment (Secondary), Mean, Kilogram (kg): Patients Diagnosed With Type 2 Diabetes -1.27 +/- 3.204 (p 0.0003)
• Change From Baseline in Blood Pressure (Systolic Blood Pressure [SBP], Diastolic Blood Pressure [DBP]) After 12 Weeks of Treatment (Secondary), Mean, Millimeters of mercury (mmHg): Patients Diagnosed With Type 2 Diabetes -2.8 +/- 13.77 (p 0.0020)
• Change From Baseline in Blood Pressure (Systolic Blood Pressure [SBP], Diastolic Blood Pressure [DBP]) After 24 Weeks of Treatment (Secondary), Mean, Millimeters of mercury (mmHg): Patients Diagnosed With Type 2 Diabetes -0.4 +/- 16.59 (p 0.7591)

Adverse events

Time frame: AE and All-cause mortality collection period: From first Esgliteo administration up to 24 weeks.

Serious adverse events by term

• Study Protocol (PDF, 2022-10-28)
• Statistical Analysis Plan (PDF, 2023-04-19)