Real-World Observational Study to Evaluate Oral and Subcutaneous Semaglutide Effectiveness in Argentine Adults with Type 2 Diabetes
Background
Type 2 Diabetes Mellitus (T2DM) is a chronic metabolic disorder characterized by elevated blood glucose levels, leading to severe microvascular and macrovascular complications. Despite advancements, achieving and maintaining optimal glycemic control remains a significant challenge for many patients globally, including in Argentina. Current standard-of-care often involves a combination of lifestyle modifications and pharmacotherapy, but adherence and long-term efficacy can vary. GLP-1 receptor agonists like semaglutide have demonstrated robust efficacy in clinical trials for glycemic control and weight management, but real-world data, particularly from diverse populations and clinical settings, are crucial to understand their broader impact and inform clinical practice.
Study Design
This prospective, multicenter, observational study aims to evaluate the real-world effectiveness and safety of oral and subcutaneous semaglutide in adult patients with Type 2 Diabetes Mellitus residing in Argentina. Participants will receive semaglutide as prescribed by their treating physician as part of routine clinical care, without specific dose or route intervention by the study. Follow-up assessments are planned at 3 months, 6 months, and 12 months after treatment initiation. The primary objective is to assess changes in glycated hemoglobin (HbA1c) from baseline. Secondary objectives include evaluating changes in body weight, waist circumference, hand-grip strength, treatment satisfaction (using the Diabetes Treatment Satisfaction Questionnaire (DTSQ)), medication adherence (using the Simplified Medication Adherence Questionnaire (SMAQ)), treatment route switching, treatment discontinuation, and adverse events.
Why It Matters
This real-world observational study is critical for understanding how semaglutide performs in a diverse clinical setting outside of highly controlled randomized trials, specifically within the Argentine population. The findings, once available, will provide valuable insights into the practical effectiveness and safety of both oral and subcutaneous formulations when used in routine clinical practice. This data can help clinicians tailor treatment strategies, optimize patient adherence, and manage expectations regarding glycemic control and weight loss in real-world scenarios. It will also shed light on patient satisfaction and the factors influencing treatment persistence and switching, which are vital for long-term diabetes management. Such real-world evidence complements clinical trial data, offering a more comprehensive picture of a drug's utility and informing local guidelines and patient counseling.
semaglutide
type-2-diabetes
observational-study
real-world-evidence
glycemic-control
weight-management