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Diabetes MellitusSEMA-REAL ARGNCT07621419

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

An observational study of Diabetes Mellitus, run by Hospital Italiano de Buenos Aires at 2 sites in Argentina.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus
What is being tested?
semaglutide
How many people
145 participants
Where
2 sitesArgentina
Study dates
4 Aug 2025to 31 Dec 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Martín L Gil Folgar, MD contact

1520497361 ext. +5411

martin.gilfolgar@hospitalitaliano.org.ar

Natalia Nachón, MD contact

155876-3407 ext. +54 9 11

dra.nachon@gmail.com

Argentina2 sites, 2 recruiting

  • Hospital Italiano de Buenos Aires

    Buenos Aires, Buenos Aires, 1199

    Martín L Gil Folgar, MD, 1520497361 ext. +5411, martin.gilfolgar@hospitalitaliano.org.ar

    Recruiting

  • Hospital General de Agudos Dr Enrique Tornú

    Buenos Aires, Buenos Aires, 1427

    María N Nachón, MD, 155876-3407 ext. +54 9 11, dra.nachon@gmail.com

    Recruiting

Other trials in Argentina

About this study

Official title: 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).

Being tested
semaglutide
Keywords
semaglutide, real world study, obesity, type II diabetes, Argentinian Society of Medicine
Medical subject headings
Diabetes Mellitus, Obesity, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • semaglutideDrug

    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.

Study groups in NCT07621419
Study groupRoleWhat they receive
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.
Receives: Drug: semaglutide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, 3 months, 6 months, and 12 months.

Secondary outcomes (8)

  1. Change in Body Weight

    Mean change in body weight (kg) compared with baseline.

    Measured: Baseline, 3 months, 6 months, and 12 months.

  2. Change in Waist Circumference

    Mean change in waist circumference (cm) compared with baseline.

    Measured: Baseline, 3 months, 6 months, and 12 months.

  3. Change in Hand-Grip Strength

    Mean change in grip strength (kg) measured with a hand dynamometer.

    Measured: Baseline, 3 months, 6 months, and 12 months.

  4. 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.

    Measured: Baseline, 3 months, 6 months, and 12 months.

  5. 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.

    Measured: Baseline, 3 months, 6 months, and 12 months.

  6. Proportion of Patients Switching Administration Route

    Percentage of participants switching between oral and subcutaneous semaglutide, including direction and reason for change.

    Measured: Up to 12 months.

  7. Reasons for Treatment Discontinuation

    Frequency and type of reasons for discontinuation (adverse events, inefficacy, patient decision, etc.).

    Measured: Up to 12 months.

  8. Adverse Events

    Incidence and severity of adverse events, categorized by system organ class and relationship to semaglutide.

    Measured: Up to 12 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2026
  2. Study start4 Aug 2025
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
145 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07621419
Sponsor's protocol ID
15820
Acronym
SEMA-REAL ARG
Status last verified
Jun 2026
First submitted
19 May 2026
Last updated
2 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 34993760

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus, run by Hospital Italiano de Buenos Aires at 2 sites in Argentina.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Martín L Gil Folgar, MD (1520497361 ext. +5411, martin.gilfolgar@hospitalitaliano.org.ar), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in glycated hemoglobin (HbA1c) levels from baseline to 3, 6, and 12 months of follow-up. (time frame: Baseline, 3 months, 6 months, and 12 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07621419, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.

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