Sex Related Outcomes in Oral vs. Subcutaneous Semaglutide in Type 2 Diabetes Mellitus: A 12-month Real-world Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 212
- 试验地点
- 1
- 主要终点
- Number of participants with HbA1c change
研究概览
简要总结
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.
详细描述
emaglutide is a GLP-1 receptor agonist approved for the treatment of type 2 diabetes mellitus (T2D), available in both once-weekly subcutaneous and once-daily oral formulations. While both have demonstrated efficacy in phase 3 trials (SUSTAIN and PIONEER programs), real-world comparative data-particularly regarding sex-based differences in response-remain limited. This prospective, observational, real-world cohort study aims to compare the 12-month metabolic efficacy and hepatic effects of oral versus subcutaneous semaglutide in patients with T2D, with a specific focus on sex-disaggregated outcomes.
A total of 212 adult outpatients with T2D diagnosed for at least one year were consecutively recruited from the Endocrinology and Metabolism Unit, University Hospital of Palermo. Patients were assigned to either oral or subcutaneous semaglutide (n = 106 per group), based on drug availability and patient preference, not clinical criteria. Both groups were matched for sex.
Inclusion criteria were: age ≥18 years, T2D diagnosis ≥1 year, no prior use of GLP-1 RAs, and baseline HbA1c >6.5% (48 mmol/mol).
Exclusion criteria included: pregnancy, participation in other interventional studies, and known hypersensitivity to semaglutide.
Patients received semaglutide titrated according to label:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
oral semaglutide
oral semaglutide
干预措施: Oral semaglutide (Drug)
subcutaneous semaglutide
subcutaneous semaglutide
干预措施: subcutaneous semaglutide (Drug)
结局指标
主要结局
Number of participants with HbA1c change
时间窗: From enrollment to 12 months
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
次要结局
未报告次要终点
研究者
Valentina Guarnotta
Principal investigator
University of Palermo