RecruitingNCT07621419

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

New Formulation of Semaglutide in the Treatment of Type 2 Diabetes in Argentina: a Prospective, Multicenter, Real-world Study


Sponsor

Hospital Italiano de Buenos Aires

Enrollment

145 participants

Start Date

Aug 4, 2025

Study Type

OBSERVATIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called semaglutide for people with diabetes mellitus. The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGsemaglutide

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.


Locations(2)

Hospital Italiano de Buenos Aires

Buenos Aires, Buenos Aires, Argentina

Hospital General de Agudos Dr Enrique Tornú

Buenos Aires, Buenos Aires, Argentina

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NCT07621419


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