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

Официальное название

New Formulation of Semaglutide in the Treatment of Type 2 Diabetes in Argentina: a Prospective, Multicenter, Real-world Study

Обзор

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).

Вмешательства

• Препарат semaglutide
  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.

Первичные конечные точки

• Change in glycated hemoglobin (HbA1c) levels from baseline to 3, 6, and 12 months of follow-up. [Срок оценки: Baseline, 3 months, 6 months, and 12 months.]

Вторичные конечные точки (8)

• Change in Body Weight [Срок оценки: Baseline, 3 months, 6 months, and 12 months.]
• Change in Waist Circumference [Срок оценки: Baseline, 3 months, 6 months, and 12 months.]
• Change in Hand-Grip Strength [Срок оценки: Baseline, 3 months, 6 months, and 12 months.]
• Treatment Satisfaction Assessed With the Diabetes Treatment Satisfaction Questionnaire [Срок оценки: Baseline, 3 months, 6 months, and 12 months.]
• Treatment Adherence Assessed With the Simplified Medication Adherence Questionnaire [Срок оценки: Baseline, 3 months, 6 months, and 12 months.]
• Proportion of Patients Switching Administration Route [Срок оценки: Up to 12 months.]
• Reasons for Treatment Discontinuation [Срок оценки: Up to 12 months.]
• Adverse Events [Срок оценки: Up to 12 months.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Аргентина · 2 центра

• Hospital Italiano de Buenos Aires — Buenos Aires
• Hospital General de Agudos Dr Enrique Tornú — Buenos Aires

Публикации

• 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. PMID 11873004
• 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. PMID 35897259
• 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. PMID 40775843
• 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. PMID 39651989
• 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. PMID 39316289
• 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. PMID 31186300
• 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. PMID 34993760

Идентификаторы

NCT: NCT07621419 · 15820

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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