PIONEER REAL Japan: Primary results from a multicenter, prospective, real-world study of oral semaglutide in adults with type 2 diabetes in Japanese clinical practice

Abstract

Aims/introduction: PIONEER REAL Japan was a non-interventional prospective study of oral semaglutide in adults with type 2 diabetes in Japanese clinical practice.

Materials and methods: Adults naïve to injectable glucose-lowering therapies initiated oral semaglutide in routine clinical practice and were followed for 34-44 weeks. The primary endpoint was change in glycated hemoglobin (HbA_1c) from baseline to end of study; the co-primary endpoint was number of adverse events (AEs). Secondary endpoints included change in bodyweight from baseline to end of study. Analyses were also carried out for subgroups aged <75 and ≥75 years.

Results: A total of 624 participants initiated oral semaglutide; 578 completed the study. Mean baseline HbA_1c and bodyweight were 7.7% and 72.4 kg, respectively. At end of study, estimated change (95% confidence interval [CI]) in HbA_1c from baseline was -0.7 percentage points (-0.77, -0.61) overall, -0.8 percentage points (-0.86, -0.67) in the <75 years subgroup and -0.5 percentage points (-0.68, -0.41) in the ≥75 years subgroup (all P < 0.0001). Estimated change (95% CI) in bodyweight was -2.8 (-3.19, -2.50) kg overall, -2.9 (-3.38, -2.49) kg in the <75 years subgroup and - 2.7 (-3.18, -2.14) kg in the ≥75 years subgroup (all P < 0.0001). AEs occurred in 161 (25.8%) participants: 99 of 423 (23.4%) and 62 of 201 (30.8%) participants in the <75 and ≥75 years subgroups, respectively. Gastrointestinal AEs were the AEs most frequently leading to oral semaglutide discontinuation.

Conclusions: In routine clinical practice, HbA_1c and bodyweight were significantly reduced from baseline in adults initiating oral semaglutide, including those aged ≥75 years, with no new safety concerns.

Keywords: Diabetes mellitus, type 2; Oral semaglutide; Prospective studies.

Figure 1

Participant disposition. Percentage values are based on the full analysis set. ^†Participants who initiated oral semaglutide treatment and attended the EoS visit. ^‡As recorded in the ‘Discontinuation of oral semaglutide form’ in the electronic case report form. ^§Participants who were receiving oral semaglutide treatment and attended the EoS visit. EoS, end of study.

Figure 2

Estimated change from baseline in glycated hemoglobin (HbA_1c; % points) at end of study (mixed model for repeated measurements adjusted, in‐study observation period, full analysis set). CI, confidence interval; N, number of participants evaluated for endpoint; SD, standard deviation.

Figure 3

Secondary efficacy endpoints in the total population and <75 years and ≥75 years subgroups. (a) Estimated change in body weight (kg) at end of study (EoS); (b) change in bodyweight (%) at EoS; (c) proportion of participants with glycated hemoglobin (HbA_1c) <7% at baseline and EoS; (d) proportion of participants with reductions from baseline in HbA_1c ≥1 percentage points and bodyweight ≥5% at EoS; (e) proportion of participants with reductions from baseline in HbA_1c ≥1 percentage points and bodyweight ≥3% at EoS (full analysis set). CI, confidence interval; n, number of participants reaching a given endpoint; N, total number of participants evaluated for a given endpoint; SD, standard deviation.