Oral Semaglutide in Routine Clinical Practice: Characteristics of People with Type 2 Diabetes Started on the Drug and Changes in Their Clinical Parameters after 24 Weeks of Treatment

Abstract

Background/Objectives: Semaglutide is the unique once-daily oral glucagon-like receptor agonist presently available. Aims of this study were to describe clinical characteristics of patients with type 2 diabetes (T2D) initiating oral semaglutide, to assess its effects on glycemic control, body weight (BW) and its tolerability in routine clinical practice. Methods: Electronic medical records from two Italian diabetes clinics were evaluated. Mean glycated hemoglobin (HbA1c) and BW were assessed in adults with T2D before and 6 months after oral semaglutide prescription. Treatment discontinuation and safety data were reported. Results: A total of 192 patients initiating oral semaglutide (44% female) presented a mean age of 66 years, a diabetes duration of 10 years, HbA1c of 7.9% and a BW of 82.6 kg. Almost 50% of patients were obese. Mean HbA1c and BW changes from baseline to follow up were -0.7% and -2.6 kg, respectively. Greater HbA1c reduction was observed in patients with baseline HbA1c ≥ 8% and with diabetes duration <5 years. The composite endpoint of HbA1c ≤7% and a weight loss ≥5% was achieved in 22.5% of the participants. A total of 40 patients (20.8%) discontinued treatment: 26 because of gastrointestinal adverse events, and 10 due to limited effectiveness in lowering HbA1c and/or BW. Conclusions: In a real clinical setting, patients initiating oral semaglutide showed suboptimal metabolic control, short diabetes duration and obesity; a significant improvement in HbA1c and BW was achieved mainly in patients with a more recent diabetes diagnosis, supporting the use of oral semaglutide in the early phase of the disease.

Keywords: GLP1 receptor agonist; cardiovascular risk factors; clinical practice; oral semaglutide; real-world evidence; type 2 diabetes.

Figure 1

Background glucose-lowering therapy before and after oral semaglutide prescription. Data are presented as the percentage (%) of use in the study population. Abbreviations: DPP4i, dipeptidyl peptidase 4 inhibitors; sodium–glucose cotransporter-2 inhibitors, SGLT2i; GLP-1RA, glucagon-like peptide 1 receptor agonists.

Figure 2

Study population divided in terciles based on the baseline HbA1c (on the left) and body weight (on the right) levels. Baseline HbA1c terciles were: tercile 1 (5.5–7.4%; n = 71); tercile 2 (7.5–8%; n = 62); tercile 3 (8.1–14.1%; n = 59). p= non-significant (n.s.) between HbA1c tercile 1 and tercile 2; p < 0.0001 between HbA1c tertile 3 and tertile 1. Baseline body weight terciles were: tercile 1 (42–73 kg; n = 54); tercile 2 (74–87 kg; n = 53); tercile 3 (89–133 kg; n = 51). Among body weight terciles, p = n.s.

Figure 3

Mean change in HbA1c from baseline (%) in all patients and in subjects stratified by disease duration and gender. Data about stratification by age, BMI categories, eGFR, and previous use of DDP4i are not shown but described in the text. *, p value versus baseline. Abbreviations: T2D, type 2 diabetes; BMI, body mass index; eGFR, estimated glomerular filtration rate; DPP4i, dipeptidyl peptidase 4 inhibitors.