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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| semaglutide | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 3 months, 6 months, and 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Weight | Mean change in body weight (kg) compared with baseline. | Baseline, 3 months, 6 months, and 12 months. |
| Change in Waist Circumference | Mean change in waist circumference (cm) compared with baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Semaglutide Dose Over Time | Evaluation of dose adjustments (increases or reductions) across follow-up visits. | Baseline, 3 months, 6 months, and 12 months. |
| Subgroup Analysis by Administration Route |
Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Martín L Gil Folgar, MD | Contact | 1520497361 | +5411 | martin.gilfolgar@hospitalitaliano.org.ar |
| Natalia Nachón, MD | Contact | 155876-3407 | +54 9 11 | dra.nachon@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| María Natalia Nachón, MD | Hospital General de Agudos Dr Enrique Tornú | Principal Investigator |
| Iván A Huespe, MD | Hospital Italiano de Buenos Aires | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Italiano de Buenos Aires | Recruiting | Buenos Aires | Buenos Aires | 1199 | Argentina |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11873004 | Background | 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. | |
| 35897259 |
| Label | URL |
|---|---|
| Statistics on the prevalence of diabetes, obesity, and related risk factors in Argentina based on national health surveys conducted by the Instituto Nacional de Estadística y Censos (INDEC). | View source |
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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.
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|
| Baseline, 3 months, 6 months, and 12 months. |
| Change in Hand-Grip Strength | Mean change in grip strength (kg) measured with a hand dynamometer. | Baseline, 3 months, 6 months, and 12 months. |
| 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. | Baseline, 3 months, 6 months, and 12 months. |
| Treatment Adherence Assessed With the Simplified Medication Adherence Questionnaire | 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. | Baseline, 3 months, 6 months, and 12 months. |
| Proportion of Patients Switching Administration Route | Percentage of participants switching between oral and subcutaneous semaglutide, including direction and reason for change. | Up to 12 months. |
| Reasons for Treatment Discontinuation | Frequency and type of reasons for discontinuation (adverse events, inefficacy, patient decision, etc.). | Up to 12 months. |
| Adverse Events | Incidence and severity of adverse events, categorized by system organ class and relationship to semaglutide. | Up to 12 months. |
Comparison of glycemic and anthropometric outcomes between patients receiving oral vs. subcutaneous semaglutide.
| Up to 12 months. |
| Matías Mirofsky, MD |
| Hospital Leónidas Lucero, Bahía Blanca |
| Study Chair |
| Hospital General de Agudos Dr Enrique Tornú | Recruiting | Buenos Aires | Buenos Aires | 1427 | Argentina |
|
| 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. |
| 40775843 | Background | 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. |
| 39651989 | Background | 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. |
| 39316289 | Background | 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. |
| 31186300 | Background | 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. |
| 34993760 | Background | 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. |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D009765 | Obesity |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
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