N/A
Completed N=1,053
Esgliteo Post Marketing Surveillance (PMS) in Korean Patients With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT05130463 ↗Enrolled (actual)
1,053
Serious AEs
0.5%
Results posted
Aug 2025
Primary outcomePrimary: All Reported Adverse Events Collected From Subjects Taking at Least One Dose of ESGLITEO® — 26 Number of events
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY All Reported Adverse Events Collected From Subjects Taking at Least One Dose of ESGLITEO® |
26 | — |
| PRIMARY Change From Baseline in Glycosylated Hemoglobin (HbA1c) After 12 Weeks of Treatment |
-0.21 | 0.0011 sig |
| PRIMARY Change From Baseline in Glycosylated Hemoglobin (HbA1c) After 24 Weeks of Treatment |
-0.27 | 0.0014 sig |
| SECONDARY Percentage of Participants With HbA1c Reaching Less Than 7% From Baseline (Target Effectiveness Response Rate) After 12 Weeks of Treatment |
49.50 | — |
| SECONDARY Percentage of Participants With HbA1c Reaching Less Than 7% From Baseline (Target Effectiveness Response Rate) After 24 Weeks of Treatment |
53.24 | — |
| SECONDARY Percentage of Participants With Occurrence of Relative Effectiveness Response After 12 Weeks of Treatment |
29.37 | — |
| SECONDARY Percentage of Participants With Occurrence of Relative Effectiveness Response After 24 Weeks of Treatment |
38.85 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) After 12 Weeks of Treatment |
-10.8 | 0.0008 sig |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks of Treatment |
-12.3 | 0.0068 sig |
| SECONDARY Change From Baseline in Body Weight After 12 Weeks of Treatment |
-0.72 | 0.1867 |
| SECONDARY Change From Baseline in Body Weight After 24 Weeks of Treatment |
-1.27 | 0.0003 sig |
| SECONDARY Change From Baseline in Blood Pressure (Systolic Blood Pressure [SBP], Diastolic Blood Pressure [DBP]) After 12 Weeks of Treatment |
-2.8; -1.6 | 0.0020 sig |
| SECONDARY Change From Baseline in Blood Pressure (Systolic Blood Pressure [SBP], Diastolic Blood Pressure [DBP]) After 24 Weeks of Treatment |
-0.4; -0.6 | 0.7591 |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05130463). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.