Efficacy and safety of oral semaglutide in Japanese patients with type 2 diabetes: A subgroup analysis by baseline variables in the PIONEER 9 and PIONEER 10 trials
Abstract Aims/Introduction To assess the impact of baseline characteristics on the efficacy and safety of oral semaglutide in Japanese patients with type 2 diabetes. Materials and Methods In the Peptide InnOvatioN for Early diabEtes tReatment (PIONEER) 9 and 10 trials, Japanese patients were randomi...
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| Format: | Article |
| Language: | English |
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Wiley
2022-06-01
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| Series: | Journal of Diabetes Investigation |
| Subjects: | |
| Online Access: | https://doi.org/10.1111/jdi.13764 |
| _version_ | 1818209788599730176 |
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| author | Daisuke Yabe Srikanth Deenadayalan Hiroshi Horio Hideaki Kaneto Thomas Bo Jensen Yasuo Terauchi Yuichiro Yamada Nobuya Inagaki |
| author_facet | Daisuke Yabe Srikanth Deenadayalan Hiroshi Horio Hideaki Kaneto Thomas Bo Jensen Yasuo Terauchi Yuichiro Yamada Nobuya Inagaki |
| author_sort | Daisuke Yabe |
| collection | DOAJ |
| description | Abstract Aims/Introduction To assess the impact of baseline characteristics on the efficacy and safety of oral semaglutide in Japanese patients with type 2 diabetes. Materials and Methods In the Peptide InnOvatioN for Early diabEtes tReatment (PIONEER) 9 and 10 trials, Japanese patients were randomized to once‐daily oral semaglutide (3, 7, or 14 mg) or a comparator (placebo or once‐daily subcutaneous liraglutide 0.9 mg in PIONEER 9; once‐weekly subcutaneous dulaglutide 0.75 mg in PIONEER 10) for 52 weeks, with 5 weeks of follow up. An exploratory analysis grouped patients in each trial according to baseline glycated hemoglobin (HbA1c; ≤8.0, >8.0–≤9.0, or >9.0%), body mass index (<25, ≥25–<30, or ≥30 kg/m2) and, for PIONEER 10 only, by background medication (sulfonylurea, glinide, thiazolidinedione, α‐glucosidase inhibitor, sodium‐glucose cotransporter 2 inhibitor). Efficacy (changes from baseline to week 26 in HbA1c and bodyweight) and safety were assessed. Results Seven hundred and one patients were included (PIONEER 9: N = 243; PIONEER 10: N = 458). In both trials, HbA1c reductions increased as baseline HbA1c increased; there were no other apparent patterns between the variables investigated and HbA1c or bodyweight changes. There was one statistically significant subgroup interaction between baseline HbA1c and estimated treatment differences in bodyweight change for oral semaglutide 14 mg versus placebo in PIONEER 9 (P = 0.0286). Baseline HbA1c, baseline body mass index and background medication did not appear to affect the proportions of patients reporting adverse events. Conclusions Oral semaglutide is effective across a range of baseline subgroups of Japanese patients with type 2 diabetes, with no unexpected safety findings. |
| first_indexed | 2024-12-12T05:06:17Z |
| format | Article |
| id | doaj.art-294dcb358ed2462e81e39e439b8d70b0 |
| institution | Directory Open Access Journal |
| issn | 2040-1116 2040-1124 |
| language | English |
| last_indexed | 2024-12-12T05:06:17Z |
| publishDate | 2022-06-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of Diabetes Investigation |
| spelling | doaj.art-294dcb358ed2462e81e39e439b8d70b02022-12-22T00:37:06ZengWileyJournal of Diabetes Investigation2040-11162040-11242022-06-0113697598510.1111/jdi.13764Efficacy and safety of oral semaglutide in Japanese patients with type 2 diabetes: A subgroup analysis by baseline variables in the PIONEER 9 and PIONEER 10 trialsDaisuke Yabe0Srikanth Deenadayalan1Hiroshi Horio2Hideaki Kaneto3Thomas Bo Jensen4Yasuo Terauchi5Yuichiro Yamada6Nobuya Inagaki7Department of Diabetes, Endocrinology and Metabolism and Department of Rheumatology and Clinical Immunology Gifu University Graduate School of Medicine Gifu JapanNovo Nordisk A/S Søborg DenmarkNovo Nordisk Pharma Ltd. Tokyo JapanDepartment of Diabetes, Endocrinology and Metabolism Kawasaki Medical School Kurashiki JapanNovo Nordisk A/S Søborg DenmarkDepartment of Endocrinology and Metabolism, Graduate School of Medicine Yokohama City University Yokohama JapanCenter for Diabetes, Endocrinology and Metabolism Kansai Electric Power Hospital Osaka JapanDepartment of Diabetes, Endocrinology and Nutrition Kyoto University Graduate School of Medicine Kyoto JapanAbstract Aims/Introduction To assess the impact of baseline characteristics on the efficacy and safety of oral semaglutide in Japanese patients with type 2 diabetes. Materials and Methods In the Peptide InnOvatioN for Early diabEtes tReatment (PIONEER) 9 and 10 trials, Japanese patients were randomized to once‐daily oral semaglutide (3, 7, or 14 mg) or a comparator (placebo or once‐daily subcutaneous liraglutide 0.9 mg in PIONEER 9; once‐weekly subcutaneous dulaglutide 0.75 mg in PIONEER 10) for 52 weeks, with 5 weeks of follow up. An exploratory analysis grouped patients in each trial according to baseline glycated hemoglobin (HbA1c; ≤8.0, >8.0–≤9.0, or >9.0%), body mass index (<25, ≥25–<30, or ≥30 kg/m2) and, for PIONEER 10 only, by background medication (sulfonylurea, glinide, thiazolidinedione, α‐glucosidase inhibitor, sodium‐glucose cotransporter 2 inhibitor). Efficacy (changes from baseline to week 26 in HbA1c and bodyweight) and safety were assessed. Results Seven hundred and one patients were included (PIONEER 9: N = 243; PIONEER 10: N = 458). In both trials, HbA1c reductions increased as baseline HbA1c increased; there were no other apparent patterns between the variables investigated and HbA1c or bodyweight changes. There was one statistically significant subgroup interaction between baseline HbA1c and estimated treatment differences in bodyweight change for oral semaglutide 14 mg versus placebo in PIONEER 9 (P = 0.0286). Baseline HbA1c, baseline body mass index and background medication did not appear to affect the proportions of patients reporting adverse events. Conclusions Oral semaglutide is effective across a range of baseline subgroups of Japanese patients with type 2 diabetes, with no unexpected safety findings.https://doi.org/10.1111/jdi.13764Glucagon‐like peptide‐1 analogGlycemic controlType 2 diabetes |
| spellingShingle | Daisuke Yabe Srikanth Deenadayalan Hiroshi Horio Hideaki Kaneto Thomas Bo Jensen Yasuo Terauchi Yuichiro Yamada Nobuya Inagaki Efficacy and safety of oral semaglutide in Japanese patients with type 2 diabetes: A subgroup analysis by baseline variables in the PIONEER 9 and PIONEER 10 trials Journal of Diabetes Investigation Glucagon‐like peptide‐1 analog Glycemic control Type 2 diabetes |
| title | Efficacy and safety of oral semaglutide in Japanese patients with type 2 diabetes: A subgroup analysis by baseline variables in the PIONEER 9 and PIONEER 10 trials |
| title_full | Efficacy and safety of oral semaglutide in Japanese patients with type 2 diabetes: A subgroup analysis by baseline variables in the PIONEER 9 and PIONEER 10 trials |
| title_fullStr | Efficacy and safety of oral semaglutide in Japanese patients with type 2 diabetes: A subgroup analysis by baseline variables in the PIONEER 9 and PIONEER 10 trials |
| title_full_unstemmed | Efficacy and safety of oral semaglutide in Japanese patients with type 2 diabetes: A subgroup analysis by baseline variables in the PIONEER 9 and PIONEER 10 trials |
| title_short | Efficacy and safety of oral semaglutide in Japanese patients with type 2 diabetes: A subgroup analysis by baseline variables in the PIONEER 9 and PIONEER 10 trials |
| title_sort | efficacy and safety of oral semaglutide in japanese patients with type 2 diabetes a subgroup analysis by baseline variables in the pioneer 9 and pioneer 10 trials |
| topic | Glucagon‐like peptide‐1 analog Glycemic control Type 2 diabetes |
| url | https://doi.org/10.1111/jdi.13764 |
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