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)

June 1, 2026 updated by: 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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

145

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Argentina
    • Buenos Aires
      • Buenos Aires, Buenos Aires, Argentina, 1199
      • Buenos Aires, Buenos Aires, Argentina, 1427
        • Recruiting
        • Hospital General de Agudos Dr Enrique Tornú
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Drug: semaglutide
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Body Weight
Time Frame: Baseline, 3 months, 6 months, and 12 months.
Mean change in body weight (kg) compared with baseline.
Baseline, 3 months, 6 months, and 12 months.
Change in Waist Circumference
Time Frame: Baseline, 3 months, 6 months, and 12 months.
Mean change in waist circumference (cm) compared with baseline.
Baseline, 3 months, 6 months, and 12 months.
Change in Hand-Grip Strength
Time Frame: Baseline, 3 months, 6 months, and 12 months.
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
Time Frame: Baseline, 3 months, 6 months, and 12 months.
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
Time Frame: Baseline, 3 months, 6 months, and 12 months.
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
Time Frame: Up to 12 months.
Percentage of participants switching between oral and subcutaneous semaglutide, including direction and reason for change.
Up to 12 months.
Reasons for Treatment Discontinuation
Time Frame: Up to 12 months.
Frequency and type of reasons for discontinuation (adverse events, inefficacy, patient decision, etc.).
Up to 12 months.
Adverse Events
Time Frame: Up to 12 months.
Incidence and severity of adverse events, categorized by system organ class and relationship to semaglutide.
Up to 12 months.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Semaglutide Dose Over Time
Time Frame: Baseline, 3 months, 6 months, and 12 months.
Evaluation of dose adjustments (increases or reductions) across follow-up visits.
Baseline, 3 months, 6 months, and 12 months.
Subgroup Analysis by Administration Route
Time Frame: Up to 12 months.
Comparison of glycemic and anthropometric outcomes between patients receiving oral vs. subcutaneous semaglutide.
Up to 12 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Italiano de Buenos Aires

Investigators

  • Principal Investigator: María Natalia Nachón, MD, Hospital General de Agudos Dr Enrique Tornú
  • Study Director: Iván A Huespe, MD, Hospital Italiano de Buenos Aires
  • Study Chair: Matías Mirofsky, MD, Hospital Leónidas Lucero, Bahía Blanca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 4, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

May 19, 2026

First Submitted That Met QC Criteria

June 1, 2026

First Posted (Actual)

June 2, 2026

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15820

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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