RecruitingNot Applicable

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

Argentina145 participantsStarted 2025-08-04

Plain-language 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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Baseline, 3 months, 6 months, and 12 months.

Trial details

NCT IDNCT07621419

SponsorHospital Italiano de Buenos Aires

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-12-31

Contact for this trial

Martín L Gil Folgar, MD

1520497361 martin.gilfolgar@hospitalitaliano.org.ar

View on ClinicalTrials.gov More Diabetes Mellitus trials