Results from a post-marketing surveillance study of empagliflozin/linagliptin (Esgliteo) in Korean patients with Type 2 Diabetes Mellitus were posted on ClinicalTrials.gov on 2025-08-27. The study observed a mean reduction in glycosylated hemoglobin (HbA1c) of -0.27% after 24 weeks of treatment, with 26 reported adverse events among participants.
Background
Type 2 Diabetes Mellitus is a chronic metabolic disorder characterized by high blood glucose levels, often leading to serious health complications if not effectively managed. Medications like empagliflozin/linagliptin are used to help control blood sugar in patients with this condition.
Trial design
This completed post-marketing surveillance (PMS) study (NCT05130463) enrolled 1053 Korean patients diagnosed with Type 2 Diabetes Mellitus. The study aimed to monitor the safety and effectiveness of empagliflozin/linagliptin (Esgliteo) in a routine clinical practice setting. The objectives included assessing adverse events and changes in glycemic parameters and other clinical measures over time.
Key results
The post-marketing surveillance collected data on both safety and effectiveness outcomes:
- A total of 26 adverse events were reported among participants taking at least one dose of empagliflozin/linagliptin.
- After 12 weeks of treatment, the mean change from baseline in glycosylated hemoglobin (HbA1c) was -0.21% (Standard Deviation 1.126), with a p-value of 0.0011.
- After 24 weeks, the mean change from baseline in HbA1c was -0.27% (Standard Deviation 0.983), with a p-value of 0.0014.
- The percentage of participants achieving HbA1c less than 7% was 49.50% after 12 weeks and 53.24% after 24 weeks.
- Mean change from baseline in Fasting Plasma Glucose (FPG) was -10.8 mg/dL (Standard Deviation 54.90) at 12 weeks (p-value 0.0008) and -12.3 mg/dL (Standard Deviation 55.76) at 24 weeks (p-value 0.0068).
- Mean change from baseline in body weight was -0.72 kg (Standard Deviation 5.583) at 12 weeks (p-value 0.1867) and -1.27 kg (Standard Deviation 3.204) at 24 weeks (p-value 0.0003).
- Mean change from baseline in blood pressure (Systolic Blood Pressure [SBP], Diastolic Blood Pressure [DBP]) was -2.8 mmHg (Standard Deviation 13.77) after 12 weeks.
What this means
These post-marketing surveillance results provide real-world data on the effectiveness and safety of empagliflozin/linagliptin in Korean patients with Type 2 Diabetes Mellitus. The observed reductions in HbA1c and Fasting Plasma Glucose, along with a decrease in body weight over 24 weeks, align with the expected benefits of this combination therapy. The relatively low number of reported adverse events further supports its safety profile in a routine clinical practice setting. The statistically significant p-values for key glycemic parameters and the 24-week body weight reduction suggest a meaningful clinical impact.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05130463, titled "Esgliteo Post Marketing Surveillance (PMS) in Korean Patients With Type 2 Diabetes Mellitus," were posted on 2025-08-27 on clinicaltrials.gov.