Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT07621419

Recruiting nowNot applicableObservational

What this study is about

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).

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionDiabetes Mellitus

Full registry criteria

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.

Treatments and study arms

semaglutide

Drug

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.

Primary outcomes

Change in glycated hemoglobin (HbA1c) levels from baseline to 3, 6, and 12 months of follow-up.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.

Study locations

2 locations were listed when this page was built. The first 40 are shown.

Hospital General de Agudos Dr Enrique Tornú🇦🇷 Buenos Aires, Buenos Aires, Argentina

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María N Nachón, MDContact

Email · Call 155876-3407

Hospital Italiano de Buenos Aires🇦🇷 Buenos Aires, Buenos Aires, Argentina

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Martín L Gil Folgar, MDContact

Email · Call 1520497361