MedTrace Logo

Oral vs. Subcutaneous Semaglutide in Type 2 Diabetes Mellitus

NCT07056803 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 212

Last updated 2025-07-17

No results posted yet for this study

Summary

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.

Conditions

  • Diabetes Mellitus Type 2

Interventions

DRUG

Oral semaglutide

Starting dose 3 mg for a month, followed by 7 mg for a month increased up to 14 mg a month

DRUG

subcutaneous semaglutide

subcutaneous semaglutide can be started at 0,25 mg a week for a month, to be increased at 0,5 mg a week, up to 1 mg a week

Sponsors & Collaborators

  • University of Palermo

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2024-06-25
Completion
2025-06-25

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07056803 on ClinicalTrials.gov