Study of Adult Patients Residing in Argentina Diagnosed With Type 2 Diabetes Treated With a New Formulation of Semaglutide, Both Oral and Subcutaneous, in a Real-world Setting at 3 Months, 6 Months, and 1 Year of Follow-up, Quantifying the Reduction in Glycated Hemoglobin (SEMA-REAL ARG)
1 de junio de 2026 actualizado por: Ivan A. Huespe, Hospital Italiano de Buenos Aires
New Formulation of Semaglutide in the Treatment of Type 2 Diabetes in Argentina: a Prospective, Multicenter, Real-world Study
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).
Descripción general del estudio
Tipo de estudio
De observación
Inscripción (Estimado)
145
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Martín L Gil Folgar, MD
- Número de teléfono: +5411 1520497361
- Correo electrónico: martin.gilfolgar@hospitalitaliano.org.ar
Copia de seguridad de contactos de estudio
- Nombre: Natalia Nachón, MD
- Número de teléfono: +54 9 11 155876-3407
- Correo electrónico: dra.nachon@gmail.com
Ubicaciones de estudio
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Buenos Aires
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Buenos Aires, Buenos Aires, Argentina, 1199
- Reclutamiento
- Hospital Italiano de Buenos Aires
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Contacto:
- Martín L Gil Folgar, MD
- Número de teléfono: +5411 1520497361
- Correo electrónico: martin.gilfolgar@hospitalitaliano.org.ar
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Buenos Aires, Buenos Aires, Argentina, 1427
- Reclutamiento
- Hospital General de Agudos Dr Enrique Tornú
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Contacto:
- María N Nachón, MD
- Número de teléfono: +54 9 11 155876-3407
- Correo electrónico: dra.nachon@gmail.com
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
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.
Descripción
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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Patients with Type 2 Diabetes Treated with Semaglutide (Oral or Subcutaneous)
This cohort includes adults aged 18 years or older with type 2 diabetes mellitus who initiate treatment with oral or subcutaneous semaglutide as prescribed by their treating physician in routine clinical practice.
The study is observational and does not assign treatment.
Dose, formulation, and route of administration are determined by the treating physician according to standard care.
|
Participants 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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in glycated hemoglobin (HbA1c) levels from baseline to 3, 6, and 12 months of follow-up.
Periodo de tiempo: Baseline, 3 months, 6 months, and 12 months.
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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.
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Baseline, 3 months, 6 months, and 12 months.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Body Weight
Periodo de tiempo: Baseline, 3 months, 6 months, and 12 months.
|
Mean change in body weight (kg) compared with baseline.
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Baseline, 3 months, 6 months, and 12 months.
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Change in Waist Circumference
Periodo de tiempo: Baseline, 3 months, 6 months, and 12 months.
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Mean change in waist circumference (cm) compared with baseline.
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Baseline, 3 months, 6 months, and 12 months.
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Change in Hand-Grip Strength
Periodo de tiempo: Baseline, 3 months, 6 months, and 12 months.
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Mean change in grip strength (kg) measured with a hand dynamometer.
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Baseline, 3 months, 6 months, and 12 months.
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Treatment Satisfaction Assessed With the Diabetes Treatment Satisfaction Questionnaire
Periodo de tiempo: Baseline, 3 months, 6 months, and 12 months.
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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.
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Baseline, 3 months, 6 months, and 12 months.
|
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Treatment Adherence Assessed With the Simplified Medication Adherence Questionnaire
Periodo de tiempo: Baseline, 3 months, 6 months, and 12 months.
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Proportion of participants classified as adherent according to the Simplified Medication Adherence Questionnaire.
Participants will be classified as adherent or non-adherent according to the questionnaire scoring rules.
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Baseline, 3 months, 6 months, and 12 months.
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Proportion of Patients Switching Administration Route
Periodo de tiempo: Up to 12 months.
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Percentage of participants switching between oral and subcutaneous semaglutide, including direction and reason for change.
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Up to 12 months.
|
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Reasons for Treatment Discontinuation
Periodo de tiempo: Up to 12 months.
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Frequency and type of reasons for discontinuation (adverse events, inefficacy, patient decision, etc.).
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Up to 12 months.
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Adverse Events
Periodo de tiempo: Up to 12 months.
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Incidence and severity of adverse events, categorized by system organ class and relationship to semaglutide.
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Up to 12 months.
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Semaglutide Dose Over Time
Periodo de tiempo: Baseline, 3 months, 6 months, and 12 months.
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Evaluation of dose adjustments (increases or reductions) across follow-up visits.
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Baseline, 3 months, 6 months, and 12 months.
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Subgroup Analysis by Administration Route
Periodo de tiempo: Up to 12 months.
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Comparison of glycemic and anthropometric outcomes between patients receiving oral vs. subcutaneous semaglutide.
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Up to 12 months.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: María Natalia Nachón, MD, Hospital General de Agudos Dr Enrique Tornú
- Director de estudio: Iván A Huespe, MD, Hospital Italiano de Buenos Aires
- Silla de estudio: Matías Mirofsky, MD, Hospital Leónidas Lucero, Bahía Blanca
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Knobel H, Alonso J, Casado JL, Collazos J, Gonzalez J, Ruiz I, Kindelan JM, Carmona A, Juega J, Ocampo A; GEEMA Study Group. Validation of a simplified medication adherence questionnaire in a large cohort of HIV-infected patients: the GEEMA Study. AIDS. 2002 Mar 8;16(4):605-13. doi: 10.1097/00002030-200203080-00012.
- Rojas-Roque C, Hernandez-Vasquez A, Azanedo D, Bendezu-Quispe G. Socioeconomic Inequalities in the Prevalence of Diabetes in Argentina: A Repeated Cross-Sectional Study in Urban Women and Men. Int J Environ Res Public Health. 2022 Jul 22;19(15):8888. doi: 10.3390/ijerph19158888.
- Burgos MA, Morales Mendez EJ, Russo MP, Martingano I, Lopez Gutierrez MP, Maccio AM, Segalini A, Plazzotta F, Otero C, Orrego N, Grande Ratti MF. Utilizing Secondary Data from Electronic Health Records for Automated Frailty Detection in Older Adults with Diabetes. Stud Health Technol Inform. 2025 Aug 7;329:179-183. doi: 10.3233/SHTI250825.
- American Diabetes Association Professional Practice Committee. 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes-2025. Diabetes Care. 2025 Jan 1;48(1 Suppl 1):S181-S206. doi: 10.2337/dc25-S009.
- Saravanan P, Bell H, Braae UC, Collins E, Deinega A, Dhatariya K, Machell A, Trent A, Strzelecka A. PIONEER REAL UK: A Multi-Centre, Prospective, Real-World Study of Once-Daily Oral Semaglutide Use in Adults with Type 2 Diabetes. Adv Ther. 2024 Nov;41(11):4266-4281. doi: 10.1007/s12325-024-02973-z. Epub 2024 Sep 24.
- Aroda VR, Rosenstock J, Terauchi Y, Altuntas Y, Lalic NM, Morales Villegas EC, Jeppesen OK, Christiansen E, Hertz CL, Haluzik M; PIONEER 1 Investigators. PIONEER 1: Randomized Clinical Trial of the Efficacy and Safety of Oral Semaglutide Monotherapy in Comparison With Placebo in Patients With Type 2 Diabetes. Diabetes Care. 2019 Sep;42(9):1724-1732. doi: 10.2337/dc19-0749. Epub 2019 Jun 11.
- Mahapatra MK, Karuppasamy M, Sahoo BM. Semaglutide, a glucagon like peptide-1 receptor agonist with cardiovascular benefits for management of type 2 diabetes. Rev Endocr Metab Disord. 2022 Jun;23(3):521-539. doi: 10.1007/s11154-021-09699-1. Epub 2022 Jan 7.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
4 de agosto de 2025
Finalización primaria (Estimado)
31 de diciembre de 2027
Finalización del estudio (Estimado)
31 de diciembre de 2028
Fechas de registro del estudio
Enviado por primera vez
19 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
1 de junio de 2026
Publicado por primera vez (Actual)
2 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
2 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
1 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del sistema endocrino
- Trastornos Nutricionales
- Enfermedades metabólicas
- Sobrenutrición
- Peso corporal
- Trastornos del metabolismo de la glucosa
- Exceso de peso
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades Nutricionales y Metabólicas
- Signos y síntomas
- Obesidad
- Diabetes Mellitus, Tipo 2
- Diabetes mellitus
- semaglutida
Otros números de identificación del estudio
- 15820
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
The study involves observational data collected from real-world clinical practice under strict confidentiality agreements and in compliance with Argentine data protection laws (Law 25.326).
Individual participant data will remain anonymized and securely stored in the REDCap database accessible only to authorized investigators.
Aggregate and de-identified results may be shared through scientific publications and conference presentations, but individual-level data will not be made publicly available to protect patient privacy.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .