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 opdateret af: 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).
Studieoversigt
Undersøgelsestype
Observationel
Tilmelding (Anslået)
145
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Martín L Gil Folgar, MD
- Telefonnummer: +5411 1520497361
- E-mail: martin.gilfolgar@hospitalitaliano.org.ar
Undersøgelse Kontakt Backup
- Navn: Natalia Nachón, MD
- Telefonnummer: +54 9 11 155876-3407
- E-mail: 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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Kontakt:
- Martín L Gil Folgar, MD
- Telefonnummer: +5411 1520497361
- E-mail: 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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Kontakt:
- María N Nachón, MD
- Telefonnummer: +54 9 11 155876-3407
- E-mail: dra.nachon@gmail.com
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: 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
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
4. august 2025
Primær færdiggørelse (Anslået)
31. december 2027
Studieafslutning (Anslået)
31. december 2028
Datoer for studieregistrering
Først indsendt
19. maj 2026
Først indsendt, der opfyldte QC-kriterier
1. juni 2026
Først opslået (Faktiske)
2. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
2. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Sygdomme i det endokrine system
- Ernæringsforstyrrelser
- Metaboliske sygdomme
- Overernæring
- Kropsvægt
- Glukosemetabolismeforstyrrelser
- Overvægtig
- Patologiske tilstande, tegn og symptomer
- Ernæringsmæssige og metaboliske sygdomme
- Tegn og symptomer
- Fedme
- Diabetes mellitus, type 2
- Diabetes mellitus
- Semaglutid
Andre undersøgelses-id-numre
- 15820
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .