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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

NCT07621419 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 145

Last updated 2026-06-02

No results posted yet for this study

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. 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).

Conditions

Interventions

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.

Sponsors & Collaborators

  • Hospital Italiano de Buenos Aires

    lead OTHER

Principal Investigators

  • María Natalia Nachón, MD · Hospital General de Agudos Dr Enrique Tornú

  • Iván A Huespe, MD · Hospital Italiano de Buenos Aires

  • Matías Mirofsky, MD · Hospital Leónidas Lucero, Bahía Blanca

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-04
Primary Completion
2027-12-31
Completion
2028-12-31
FDA Drug
Yes

Countries

  • Argentina

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Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07621419 on ClinicalTrials.gov