Semaglutide versus GLP-1 agonists. Effectiveness, safety, and quality of life in patients with diabetes mellitus 2. The SEVERAL study

Abstract

Objective: The cardiovascular disease is the first cause of deaths in patients with diabetes mellitus 2. The objective is to evaluate and compare the weight loss in patients with diabetes treated with the different GLP-1 receptor agonists for the first time. Secondary endpoints are glycosylated hemoglobin reduction, changes in quality of life and physical activity and the safety of these drugs. Method: It is a postauthorization, multicenter, non-randomized and prospective study. 360 Patients that will start treatment for the first time with GLP-1 receptor agonists will be recruited in 10 centers in the National Health System for a period of 6 months and 44 weeks of follow-up. The primary endpoint will be weight loss achieved with the different GLP-1 receptor agonists and the secondary endpoint will be glycosylated hemoRecibido globin reduction, changes in the quality of life through the EuroQol-5D and changes physical activity through the SF-12 questionnaire, and also the safety of these drugs. The estimate recruitment period will be 6 months, from 1 December 2021 to 1 May 2022. The follow up will finish in December 2022. Discussion: The SEVERAL study will try to provide information about weight loss efficacy, changes in quality of life, physical activity and safety of the GLP-1 receptor agonists in patients with diabetes that start treatment with these drugs in the real life. This study try to compare different GLP-1 receptor agonists in terms of effectiveness and safety for a better posterior election when these drugs are used in patients with diabetes mellitus 2 and obesity.