Efficacy and safety of oral semaglutide in Chinese participants with type 2 diabetes: Subgroup analyses by baseline characteristics in the PIONEER 11 and 12 randomised controlled trials.

AIMS

This post hoc analysis investigates the impact of baseline characteristics on the efficacy and safety of oral semaglutide in a Chinese population with type 2 diabetes.

MATERIALS AND METHODS

Chinese participants from the PIONEER 11 and 12 trials with type 2 diabetes aged ≥18 years were randomised to once-daily oral semaglutide 3, 7, or 14 mg, or placebo (PIONEER 11) or sitagliptin 100 mg (PIONEER 12). Changes from baseline in HbA and body weight at week 26 were analysed in subgroups according to the following baseline characteristics: age, HbA, body mass index, duration of diabetes, and presence of gastrointestinal disease. Adverse events (AEs) by baseline subgroups were also assessed.

RESULTS

In total, 390 (PIONEER 11) and 1084 (PIONEER 12) Chinese participants with type 2 diabetes were evaluated. Most baseline characteristics were similar across the two trials in the different subgroups. Overall, greater reductions in HbA and body weight were observed with oral semaglutide versus comparators across the subgroups. A significant difference was observed for change in HbA by baseline HbA subgroups (p <0.05), with greater reductions observed in the subgroups with higher baseline HbA. Most AEs were gastrointestinal-related and mild-to-moderate.

CONCLUSIONS/INTERPRETATION: Oral semaglutide reduces HbA and body weight across a range of baseline subgroups in a Chinese population with type 2 diabetes without any unexpected additional safety concerns. These results support the use of oral semaglutide in a broad population in clinical practice.