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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
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

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Policlinico "Paolo Giaccone"
Coordinator of this site? Confirm its status
PalermoItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.