NCT07056803Completed
Oral vs. Subcutaneous Semaglutide in Type 2 Diabetes Mellitus
Sex Related Outcomes in Oral vs. Subcutaneous Semaglutide in Type 2 Diabetes Mellitus: A 12-month Real-world Study
Source: ClinicalTrials.gov · Last updated 17 Jul 2025
Brief summary (registry, in English)
This real-world, comparative cohort study aims to evaluate the 12-month effectiveness of oral versus subcutaneous semaglutide in patients with type 2 diabetes mellitus (T2D), with a specific focus on sex-based differences in metabolic response. A total of 212 patients were enrolled and evenly assigned to either oral or subcutaneous semaglutide. The primary outcome was the change in HbA1c, while secondary outcomes included variations in weight, lipid profile, liver function, and hepatic steatosis index. Subcutaneous semaglutide resulted in greater improvements in HbA1c, weight, and LDL cholesterol in men, while women exhibited a more favorable hepatic response. These findings support the need for sex-specific considerations in T2D therapy personalization.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 212 (actual)
- First submitted
- 29 Jun 2025
- Start date
- 1 Jan 2024
- Primary completion date
- 25 Jun 2024
- Lead sponsor
- University of Palermo
- Diseases
- Type 2 diabetes
- NCT number
- NCT07056803
What you commit to
- Study type: Observational
- Participants enrolled: 212
- From 1 Jan 2024 to the primary completion date, 25 Jun 2024
- 1 site 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
- known allergy or hypersensitivity to semaglutide
Other
- pregnancy
- participation in another clinical trial during the treatment period
Who the study is looking for
- age over 18 years
- diagnosis of T2D at least one year before the recruitment
- no treatment with prior GLP-1 RA
- baseline HbA1c \>6.5% (48 mmol/mol)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Policlinico "Paolo Giaccone" Coordinator of this site? Confirm its status | Palermo | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.