Oral vs. Subcutaneous Semaglutide in Type 2 Diabetes Mellitus

Sponsor
University of Palermo
Study ID
NCT07056803
Status
Completed

Conditions

  • Diabetes Mellitus Type 2

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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
  • 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

Study Details

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.

Key Dates

Start date
Jan 1, 2024
Status verified
Jul 2025
Primary completion
Jun 25, 2024
Completion
Jun 25, 2025

Study Design

Enrollment
212 participants (actual)

Arms

  • Arm: oral semaglutide
    oral semaglutide
  • Arm: subcutaneous semaglutide
    subcutaneous semaglutide

Primary Outcome Measure

Number of participants with HbA1c change [ Time Frame: From enrollment to 12 months ]

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