The goal of this prospective, multicenter, observational study is to evaluate the real-world effectiveness and safety of oral and subcutaneous semaglutide in adults with type 2 diabetes mellitus in Argentina. The main objective is to assess changes in glycated hemoglobin (HbA1c) from baseline to 3, 6, and 12 months after treatment initiation. Secondary objectives include evaluating changes in body weight, waist circumference, hand-grip strength, treatment satisfaction, medication adherence, treatment route switching, treatment discontinuation, and adverse events.
Participants will receive semaglutide as prescribed by their treating physician as part of routine clinical care. Follow-up assessments will be performed at 3, 6, and 12 months to collect clinical, laboratory, safety, treatment satisfaction, and adherence data. Treatment satisfaction will be assessed using the Diabetes Treatment Satisfaction Questionnaire (DTSQ), and adherence will be assessed using the Simplified Medication Adherence Questionnaire (SMAQ).
Age ≥ 18 years.
Clinical diagnosis of type 2 diabetes mellitus.
Baseline glycated hemoglobin (HbA1c) >7% and ≤12%.
Initiating treatment with semaglutide (oral or subcutaneous) prescribed by the treating physician according to clinical judgment.
Pregnancy or lactation at the time of enrollment.
History of severe hypersensitivity or adverse reactions to glucagon-like peptide-1 (GLP-1) receptor agonists.
Contraindications to semaglutide as listed in the product label (e.g., severe gastrointestinal disease, certain endocrine tumors).
Any other serious medical condition that, in the investigator's opinion, may interfere with study participation or data interpretation.
Study participants will be selected from adult patients with type 2 diabetes receiving routine medical care at outpatient endocrinology and internal medicine clinics across multiple centers in Argentina.
Cohort
Prospective
semaglutide
DrugParticipants will receive semaglutide as part of their usual medical care for type 2 diabetes mellitus. The intervention of interest includes both oral and subcutaneous formulations of semaglutide, prescribed and dosed at the discretion of the treating physician according to routine clinical practice.
Change in glycated hemoglobin (HbA1c) levels from baseline to 3, 6, and 12 months of follow-up.
Mean change in HbA1c (%) compared with baseline among adult patients with type 2 diabetes treated with oral or subcutaneous semaglutide in real-world clinical practice.
Change in Body Weight
Mean change in body weight (kg) compared with baseline.
Change in Waist Circumference
Mean change in waist circumference (cm) compared with baseline.
Change in Hand-Grip Strength
Mean change in grip strength (kg) measured with a hand dynamometer.
Treatment Satisfaction Assessed With the Diabetes Treatment Satisfaction Questionnaire
Change from baseline in treatment satisfaction assessed using the Diabetes Treatment Satisfaction Questionnaire. The total treatment satisfaction score ranges from 0 to 36, with higher scores indicating greater treatment satisfaction.
Change in Semaglutide Dose Over Time
Evaluation of dose adjustments (increases or reductions) across follow-up visits.
Subgroup Analysis by Administration Route
Comparison of glycemic and anthropometric outcomes between patients receiving oral vs. subcutaneous semaglutide.
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