Oral vs. Subcutaneous Semaglutide in Type 2 Diabetes Mellitus

NCT07056803 | Completed

• 1 other identifier: 04
• Study Type: observational
• Target: 212
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Number of participants with HbA1c change

  assess the change in HbA1c in patients treated with oral vs. subcutaneous semaglutide both in the entire cohort of patients and stratified by sex, over a 12-month period

  From enrollment to 12 months

Study Arms (2)

oral semaglutide

oral semaglutide

Drug: Oral semaglutide

subcutaneous semaglutide

subcutaneous semaglutide

Drug: subcutaneous semaglutide

Interventions

Oral semaglutide DRUG

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

oral semaglutide

subcutaneous semaglutide DRUG

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

subcutaneous semaglutide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study investigated a population of adult outpatients with T2D diagnosed for at least 1 year, followed at the Endocrinology and Metabolism Division of the University Hospital of Palermo

You may not qualify if:

• pregnancy
• known allergy or hypersensitivity to semaglutide
• participation in another clinical trial during the treatment period
• 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)

Sponsors & Collaborators

• University of Palermo: lead

Study Sites (1)

Policlinico Paolo Giaccone

Palermo, 90127, Italy

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 29, 2025
• First Posted: July 9, 2025
• Study Start: January 1, 2024
• Primary Completion: June 25, 2024
• Study Completion: June 25, 2025
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR

Locations

IT (1)