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 oppdatert av: 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).
Studieoversikt
Studietype
Observasjonsmessig
Registrering (Antatt)
145
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Martín L Gil Folgar, MD
- Telefonnummer: +5411 1520497361
- E-post: martin.gilfolgar@hospitalitaliano.org.ar
Studer Kontakt Backup
- Navn: Natalia Nachón, MD
- Telefonnummer: +54 9 11 155876-3407
- E-post: dra.nachon@gmail.com
Studiesteder
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Buenos Aires
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Buenos Aires, Buenos Aires, Argentina, 1199
- Rekruttering
- Hospital Italiano de Buenos Aires
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Ta kontakt med:
- Martín L Gil Folgar, MD
- Telefonnummer: +5411 1520497361
- E-post: martin.gilfolgar@hospitalitaliano.org.ar
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Buenos Aires, Buenos Aires, Argentina, 1427
- Rekruttering
- Hospital General de Agudos Dr Enrique Tornú
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Ta kontakt med:
- María N Nachón, MD
- Telefonnummer: +54 9 11 155876-3407
- E-post: dra.nachon@gmail.com
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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.
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in glycated hemoglobin (HbA1c) levels from baseline to 3, 6, and 12 months of follow-up.
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Body Weight
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Semaglutide Dose Over Time
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: María Natalia Nachón, MD, Hospital General de Agudos Dr Enrique Tornú
- Studieleder: Iván A Huespe, MD, Hospital Italiano de Buenos Aires
- Studiestol: Matías Mirofsky, MD, Hospital Leónidas Lucero, Bahía Blanca
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
4. august 2025
Primær fullføring (Antatt)
31. desember 2027
Studiet fullført (Antatt)
31. desember 2028
Datoer for studieregistrering
Først innsendt
19. mai 2026
Først innsendt som oppfylte QC-kriteriene
1. juni 2026
Først lagt ut (Faktiske)
2. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
2. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
1. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Sykdommer i det endokrine systemet
- Ernæringsforstyrrelser
- Metabolske sykdommer
- Overernæring
- Kroppsvekt
- Glukosemetabolismeforstyrrelser
- Overvektig
- Patologiske tilstander, tegn og symptomer
- Ernæringsmessige og metabolske sykdommer
- Tegn og symptomer
- Overvekt
- Diabetes mellitus, type 2
- Sukkersyke
- semaglutid
Andre studie-ID-numre
- 15820
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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