Background: The oral formulation of semaglutide, a GLP-1R agonist, has emerged as a promising treatment option for diabesity, demonstrating efficacy in both glycemic parameter improvement and weight management.

Materials and Methods: Following market launch in India in 2022, we conducted a prospective, observational cohort study across eight Indian centers to examine the initial utilization patterns of oral semaglutide in routine clinical practice. The present study enrolled subjects diagnosed with type 2 diabetes who possessed one year of follow-up data on oral semaglutide use.

Results: A multi-center, open-label, single-arm study evaluated the efficacy and safety of oral semaglutide monotherapy in 152 patients with type 2 diabetes mellitus. The mean age of the participants was 50.14 years, and the majority were male (59.86%). The baseline characteristics included a mean body mass index of 29.82 kg/m2, a mean body weight of 87.17 kg, and a mean HbA1c of 9.09%. A significant portion of the study population had comorbidities, including hypertension (46%), dyslipidemia (41%), and hypothyroidism (16%). At baseline, 81.7% of patients were initiated on the 3 mg dose of oral semaglutide. The primary outcome measures were the change in HbA1c and body weight from baseline to the follow-up visit after 1 year. The mean reduction in HbA1c and body weight was 1.81% and 5.03 kg, respectively (P < 0.0001 for both). The most common adverse events reported were generalized weakness, nausea, dryness of mouth, and diarrhea. Notably, no hypoglycemia, other serious adverse events, or discontinuations were observed.

Conclusions: Over a 12-month period, individuals with T2DM demonstrated significant improvements in key glycemic parameters, including HbA1c, and reduction in body weight, highlighting the potential of oral semaglutide as a first-line therapeutic option for this population.

Disclosure

S. Bhattacharyya: None.

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