Evaluating the Clinical Effectiveness and Safety of Semaglutide in Individuals with Uncontrolled Type2 Diabetes. Real-World Evidence from Saudi Arabia: The Observational, Multicenter, 15-Month EVOLUTION Study.

Abstract

This study aimed to assess the safety and effectiveness of semaglutide, administered either by weekly subcutaneous (SC) injection or orally, in real-life practice in Saudi Arabia in individuals with type2 diabetes mellitus (T2DM). A retrospective chart review study was conducted at 18 Saudi Arabia centers. An accredited centralized institutional review board approved the study. Medical records were included for individuals of any age ≥ 18years with uncontrolled T2DM. The primary outcome measure was the laboratory glycated hemoglobin (HbA1c) level.Secondary measures included fasting blood glucose (FBG), weight, and hypoglycemia. All variables were checked after 6 and 12months of semaglutide initiation. The analysis of this study included 1223 patients with uncontrolled T2DM (HbA1c > 7%). The mean (SD) baseline HbA1c was 10.02% (1.17). HbA1c was reduced by an average of 3.02% (0.84) and 3.17% (0.84) at 6 and 12months, respectively. Results of a repeated measure analysis of variance (ANOVA) indicated significant differences in HbA1c (pvalue < 0.001). HbA1c levels at 6 and 12months were significantly lower, 7.00% (0.70) and 6.85% (0.69), than at baseline, 10.02% (1.17). About 193 patients (56.4%) of the 295 patients having HbA1c < 9% achieved HbA1c of 5.7% or less. The frequency of hypoglycemia events was 4.60 (1.10) in the 3months before semaglutide was initiated. The frequency of hypoglycemia events in the last 3months was 2.30 (0.80) events and 0.80 (0.50) events at 6-month and 12-month follow-up visits, respectively. The percent reduction in body mass index (BMI) was an average of 13.07% (1.53) and 19.89% (4.07) at 6 and 12months, respectively. Lipid profile and blood pressure were improved at 6 and 12months. Semaglutide, administered either by SC injection or orally, provided substantial glycemic and weight-loss benefits in adults with T2DM.