Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07621419

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

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).

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Diabetes Mellitus Body Weight Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

    Time frame: 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.

Secondary outcomes

  1. Change in Body Weight

    Time frame: Baseline, 3 months, 6 months, and 12 months.

    Mean change in body weight (kg) compared with baseline.

  2. Change in Waist Circumference

    Time frame: Baseline, 3 months, 6 months, and 12 months.

    Mean change in waist circumference (cm) compared with baseline.

  3. Change in Hand-Grip Strength

    Time frame: Baseline, 3 months, 6 months, and 12 months.

    Mean change in grip strength (kg) measured with a hand dynamometer.

  4. Treatment Satisfaction Assessed With the Diabetes Treatment Satisfaction Questionnaire

    Time frame: Baseline, 3 months, 6 months, and 12 months.

    Change from baseline in treatment satisfaction assessed using the Diabetes Treatment Satisfaction Questionnaire. The total treatment satisfaction score ranges from 0 to 36, with higher scores indicating greater treatment satisfaction.

  5. Treatment Adherence Assessed With the Simplified Medication Adherence Questionnaire

    Time frame: Baseline, 3 months, 6 months, and 12 months.

    Proportion of participants classified as adherent according to the Simplified Medication Adherence Questionnaire. Participants will be classified as adherent or non-adherent according to the questionnaire scoring rules.

  6. Proportion of Patients Switching Administration Route

    Time frame: Up to 12 months.

    Percentage of participants switching between oral and subcutaneous semaglutide, including direction and reason for change.

  7. Reasons for Treatment Discontinuation

    Time frame: Up to 12 months.

    Frequency and type of reasons for discontinuation (adverse events, inefficacy, patient decision, etc.).

  8. Adverse Events

    Time frame: Up to 12 months.

    Incidence and severity of adverse events, categorized by system organ class and relationship to semaglutide.

Other outcomes

  1. Change in Semaglutide Dose Over Time

    Time frame: Baseline, 3 months, 6 months, and 12 months.

    Evaluation of dose adjustments (increases or reductions) across follow-up visits.

  2. Subgroup Analysis by Administration Route

    Time frame: Up to 12 months.

    Comparison of glycemic and anthropometric outcomes between patients receiving oral vs. subcutaneous semaglutide.

Study contacts

Contact information is provided by the study sponsor or research team.

Martín L Gil Folgar, MD

CONTACT

[email protected]

1520497361 ext. +5411

Natalia Nachón, MD

CONTACT

[email protected]

155876-3407 ext. +54 9 11

Sponsors and collaborators

Lead sponsor

Hospital Italiano de Buenos Aires

Other

Registry information

Official study title

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

Acronym: SEMA-REAL ARG

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jun 2, 2026
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.