Real-World Cohort Study of Semaglutide in Adults with Type 2 Diabetes Using an Electronic Health Records Database in Tianjin, China.

INTRODUCTION: The aim of this study was to evaluate changes in clinical parameters among adults with type 2 diabetes (T2D) after initiating subcutaneous semaglutide in Chinese clinical practice. METHODS: SCHOLAR was a retrospective cohort study using data from the Tianjin regional electronic health records database, including adults with T2D who initiated once-weekly semaglutide (full analysis set [FAS]). Endpoints included change in glycated hemoglobin (HbA) and proportion with HbA < 7.0% at month 6 (primary)/12 (secondary); lipids, medication classes, and safety (exploratory endpoints). RESULTS: Among 26,859 individuals (FAS), mean ± SD age was 57 ± 13 years, and duration of T2D was 4 ± 3 years. Individuals with HbA measurements at baseline and month 6 (n = 3055; baseline HbA 7.65%) and 12 (n = 2897; baseline HbA 7.75%) were included in the HbA analyses. Mean change (95% CI) in HbA was - 0.65%-points (- 0.71, - 0.59) at month 6, and - 0.47%-points (- 0.53, - 0.41) at month 12 with semaglutide (both p < 0.0001). The proportion of individuals with HbA < 7.0% was 40.4%, 57.9%, and 49.8% at baseline, month 6, and month 12, respectively. Additionally, for individuals with HbA ≥ 7.0% at baseline (mean HbA 8.59%), mean HbA change (95% CI) at month 6 was - 1.17%-points (- 1.25, - 1.08) (p < 0.0001). Total cholesterol, low-density lipoprotein cholesterol, and triglycerides significantly decreased after 12 months with semaglutide (p < 0.05). Among individuals with continued semaglutide use, mean daily insulin dose, and number of combined oral antidiabetic, antihypertensive, and lipid-lowering medication classes reduced after 6/12 months (all p < 0.05). In the FAS, constipation, diarrhea, and abdominal discomfort were the most frequently reported adverse events (1.73%, 0.91%, and 0.89%, respectively). CONCLUSIONS: Initiating once-weekly semaglutide was associated with significant improvements versus baseline in glycemic control and lipids in people with T2D from Tianjin, China. Safety of semaglutide was similar to the established safety profile per adverse events assessment. CLINICAL TRIALS REGISTRATION: NCT06351748.