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

Overview

Journal J Diabetes Investig

Specialty Endocrinology

Date 2024 Aug 22

PMID 39172634

Authors

Daisuke Yabe

Yoshiyuki Hamamoto

Daiji Kawanami

Rimei Nishimura

Yasuo Terauchi

Hanan Amadid

Uffe Christian Braae

Atheline Major-Pedersen

Ryo Suzuki

Affiliations

Soon will be listed here.

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) 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 and bodyweight were 7.7% and 72.4 kg, respectively. At end of study, estimated change (95% confidence interval [CI]) in HbA 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 and bodyweight were significantly reduced from baseline in adults initiating oral semaglutide, including those aged ≥75 years, with no new safety concerns.

Citing Articles

A Bioequivalence Study of Two Formulations of Oral Semaglutide in Healthy Participants.

Nielsen M, Brondsted L, Kankam M, Morelli G, Nguyen D, Skjoth T Diabetes Ther. 2024; 16(2):269-287.

PMID: 39708086 PMC: 11794934. DOI: 10.1007/s13300-024-01674-8.

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