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 juni 2026 bijgewerkt door: 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).
Studie Overzicht
Studietype
Observationeel
Inschrijving (Geschat)
145
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Martín L Gil Folgar, MD
- Telefoonnummer: +5411 1520497361
- E-mail: martin.gilfolgar@hospitalitaliano.org.ar
Studie Contact Back-up
- Naam: Natalia Nachón, MD
- Telefoonnummer: +54 9 11 155876-3407
- E-mail: dra.nachon@gmail.com
Studie Locaties
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Buenos Aires
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Buenos Aires, Buenos Aires, Argentinië, 1199
- Werving
- Hospital Italiano de Buenos Aires
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Contact:
- Martín L Gil Folgar, MD
- Telefoonnummer: +5411 1520497361
- E-mail: martin.gilfolgar@hospitalitaliano.org.ar
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Buenos Aires, Buenos Aires, Argentinië, 1427
- Werving
- Hospital General de Agudos Dr Enrique Tornú
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Contact:
- María N Nachón, MD
- Telefoonnummer: +54 9 11 155876-3407
- E-mail: dra.nachon@gmail.com
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
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.
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
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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.
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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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in glycated hemoglobin (HbA1c) levels from baseline to 3, 6, and 12 months of follow-up.
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in Body Weight
Tijdsspanne: Baseline, 3 months, 6 months, and 12 months.
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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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in Semaglutide Dose Over Time
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Hoofdonderzoeker: María Natalia Nachón, MD, Hospital General de Agudos Dr Enrique Tornú
- Studie directeur: Iván A Huespe, MD, Hospital Italiano de Buenos Aires
- Studie stoel: Matías Mirofsky, MD, Hospital Leónidas Lucero, Bahía Blanca
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
4 augustus 2025
Primaire voltooiing (Geschat)
31 december 2027
Studie voltooiing (Geschat)
31 december 2028
Studieregistratiedata
Eerst ingediend
19 mei 2026
Eerst ingediend dat voldeed aan de QC-criteria
1 juni 2026
Eerst geplaatst (Werkelijk)
2 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
2 juni 2026
Laatste update ingediend die voldeed aan QC-criteria
1 juni 2026
Laatst geverifieerd
1 juni 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 15820
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Beschrijving IPD-plan
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.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Ja
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .