NCT07621419Recruiting
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
Source: ClinicalTrials.gov · Last updated 2 Jun 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 145 (estimated)
- First submitted
- 19 May 2026
- Start date
- 4 Aug 2025
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Diseases
- Obesity, Type 1 diabetes, Type 2 diabetes
- NCT number
- NCT07621419
What you commit to
- Study type: Observational
- Planned participants: 145
- From 4 Aug 2025 to the primary completion date, 31 Dec 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Pregnancy or lactation at the time of enrollment.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Italiano de Buenos Aires Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Recruiting |
| Hospital General de Agudos Dr Enrique Tornú Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.