Ozempic (Semaglutide) Post-Marketing Surveillance Initiated for Real-World Safety and Effectiveness in Korean T2DM

Type 2 Diabetes Mellitus (T2DM) is a chronic metabolic disorder characterized by elevated blood glucose levels due to insulin resistance and/or insufficient insulin production. Despite advancements, many patients struggle to achieve optimal glycemic control, leading to severe microvascular and macrovascular complications. Glucagon-like peptide-1 receptor (GLP-1R) agonists like semaglutide offer significant benefits in glycemic control and weight management, but their real-world performance and safety profile in diverse populations, particularly in specific ethnic groups like Koreans, require ongoing evaluation beyond controlled clinical trials. This study addresses the gap in understanding long-term safety and effectiveness in routine clinical practice.

This is a multi-center, open-label, non-interventional Regulatory Post Marketing Surveillance (rPMS) study. It aims to evaluate the safety and effectiveness of Ozempic (Semaglutide) initiated according to its label in adult patients with Type 2 Diabetes Mellitus in routine clinical practice in Korea. Participants will receive Ozempic as prescribed by their study doctor, with no specific dose or route mandated by the protocol beyond standard clinical practice. The study duration is approximately 26 weeks, focusing on collecting real-world data on adverse events and clinical outcomes. This design allows for observation of the drug's performance in a broader, less controlled patient population than typical randomized controlled trials, reflecting actual usage patterns.

This record describes the protocol for a regulatory post-marketing surveillance study, and as such, specific results on safety and effectiveness are not yet available. The study's primary objective is to collect real-world data on adverse events and clinical outcomes for Ozempic (Semaglutide) in Korean patients with Type 2 Diabetes Mellitus over a 26-week period.

The study aims to provide crucial insights into the drug's performance and safety profile under routine clinical conditions, complementing data from pre-market clinical trials. Further details regarding specific efficacy endpoints (e.g., HbA1c reduction, weight loss) and safety outcomes will be reported upon study completion. This observational approach is vital for identifying rare side effects or long-term trends not evident in shorter, more controlled trials.