Real-World Usage of Once-Daily Oral Semaglutide in Adults with Type 2 Diabetes: Findings from PIONEER REAL India.

INTRODUCTION: The PIONEER REAL India study assessed the effectiveness of oral semaglutide in adults with type 2 diabetes (T2D). METHODS: This was a 34-44-week, multicenter, non-interventional study in participants who had not previously received injectable glucose-lowering medications and had initiated treatment with oral semaglutide. Change in HbA from baseline to end-of-study (EoS) was the primary endpoint. Change in body weight, proportion of participants achieving HbA <7% and HbA reduction ≥1%-points plus body weight reduction ≥3% or ≥5%, also changes in HbA by baseline HbA (≤9% and >9%) from baseline to EoS were assessed. Here, we present the results from on-treatment analyses. RESULTS: Of 388 enrolled, 70.1% of participants completed the study. At baseline, the mean age and T2D duration of the study population were 50.1 and 6.3 years; mean HbA and body weight were 9.0% and 89.0 kg, respectively. Estimated mean changes (95% confidence interval, CI) in HbA and body weight were - 1.78%-points (-1.88, -1.68; < 0.0001) and - 7.23 kg (-7.84, -6.63; < 0.0001), respectively. At EoS, 34.2% achieved HbA <7%. Estimated mean HbA changes (95% CI) for participants with baseline HbA ≤9% and >9% were - 0.93%-points (-1.07, -0.79; < 0.0001) and - 2.48%-points (-2.60, -2.35; < 0.0001), respectively. No new safety signals were observed. CONCLUSIONS: Individuals with T2D treated with once-daily oral semaglutide experienced significant reductions in HbA and body weight, without any new safety events. These findings will add to the decision-making for initiating oral semaglutide in individuals with T2D in India. NCT05502562.