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 HbA1c from baseline to end-of-study (EoS) was the primary endpoint. Change in body weight, proportion of participants achieving HbA1c <7% and HbA1c reduction ≥1%-points plus body weight reduction ≥3% or ≥5%, also changes in HbA1c by baseline HbA1c (≤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 HbA1c and body weight were 9.0% and 89.0 kg, respectively. Estimated mean changes (95% confidence interval, CI) in HbA1c and body weight were - 1.78%-points (-1.88, -1.68; P < 0.0001) and - 7.23 kg (-7.84, -6.63; P < 0.0001), respectively. At EoS, 34.2% achieved HbA1c <7%. Estimated mean HbA1c changes (95% CI) for participants with baseline HbA1c ≤9% and >9% were - 0.93%-points (-1.07, -0.79; P < 0.0001) and - 2.48%-points (-2.60, -2.35; P < 0.0001), respectively. No new safety signals were observed.

CONCLUSIONS

Individuals with T2D treated with once-daily oral semaglutide experienced significant reductions in HbA1c 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.Trial registration: NCT05502562.