Real-world clinical evidence of oral semaglutide on metabolic abnormalities in subjects with type 2 diabetes: a multicenter retrospective observational study (the Sapporo-Oral SEMA study)
Oral semaglutide has potent anti-hyperglycemic efficacy in phase III trials. However, the complicated dosing instructions hamper to use this drug; therefore, we evaluated the efficacy and safety of oral semaglutide in subjects with type 2 diabetes in a real-world clinical setting. In this multi-cent...
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The Japan Endocrine Society
2024-06-01
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| Series: | Endocrine Journal |
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| Online Access: | https://www.jstage.jst.go.jp/article/endocrj/71/6/71_EJ23-0648/_html/-char/en |
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| author | Sho Furusawa Hiroshi Nomoto Chiho Oba-Yamamoto Jun Takeuchi Miki Ito Hiroyoshi Kurihara Shin Aoki Aika Miya Hiraku Kameda Akinobu Nakamura Tatsuya Atsumi |
| author_facet | Sho Furusawa Hiroshi Nomoto Chiho Oba-Yamamoto Jun Takeuchi Miki Ito Hiroyoshi Kurihara Shin Aoki Aika Miya Hiraku Kameda Akinobu Nakamura Tatsuya Atsumi |
| author_sort | Sho Furusawa |
| collection | DOAJ |
| description | Oral semaglutide has potent anti-hyperglycemic efficacy in phase III trials. However, the complicated dosing instructions hamper to use this drug; therefore, we evaluated the efficacy and safety of oral semaglutide in subjects with type 2 diabetes in a real-world clinical setting. In this multi-center retrospective observational study, we analyzed subjects with type 2 diabetes newly treated with an oral semaglutide for >6 months at four medical centers located in Sapporo, Japan. The changes in glycated hemoglobin, body weight, and other metabolic parameters were evaluated and any adverse event leading to semaglutide discontinuation were recorded from February 2021 to December 2022. This study was registered with the University Hospital Medical Information Network Center (UMIN000050583). Of 543 subjects who met the inclusion criteria, data for 434 subjects (age 55.5 ± 12.6 years; body mass index 29.6 ± 6.0 kg/m2) were analyzed. After a 6 months of observation period, semaglutide 3 mg, 7 mg, or 14 mg was used by 55 (12.7%), 241 (55.5%), and 138 (31.8%) of subjects, respectively. Both glycated hemoglobin and body weight significantly improved: 7.65 ± 1.11% to 6.88 ± 0.91% (p < 0.001) and 80.2 ± 19.2 kg to 77.6 ± 19.2 kg (p < 0.001), respectively. Efficacy was also confirmed in the subgroup switched from other anti-hyperglycemic agents, including dipeptidyl peptidase-4 inhibitors. In total, 154 subjects had symptomatic gastrointestinal symptoms and 39 (7.2%) were discontinued semaglutide due to the adverse events. None of the participants experienced severe hypoglycemic events. Oral semaglutide in subjects with type 2 diabetes improved glycemic control and body weight in a real-world clinical setting. |
| format | Article |
| id | doaj-art-248049dd9a5c4e8c94aa8491ee12b524 |
| institution | Kabale University |
| issn | 1348-4540 |
| language | English |
| publishDate | 2024-06-01 |
| publisher | The Japan Endocrine Society |
| record_format | Article |
| series | Endocrine Journal |
| spelling | doaj-art-248049dd9a5c4e8c94aa8491ee12b5242025-01-22T05:07:43ZengThe Japan Endocrine SocietyEndocrine Journal1348-45402024-06-0171660361610.1507/endocrj.EJ23-0648endocrjReal-world clinical evidence of oral semaglutide on metabolic abnormalities in subjects with type 2 diabetes: a multicenter retrospective observational study (the Sapporo-Oral SEMA study)Sho Furusawa0Hiroshi Nomoto1Chiho Oba-Yamamoto2Jun Takeuchi3Miki Ito4Hiroyoshi Kurihara5Shin Aoki6Aika Miya7Hiraku Kameda8Akinobu Nakamura9Tatsuya Atsumi10Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo 060-8638, JapanDepartment of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo 060-8638, JapanSapporo Diabetes and Thyroid Clinic, Sapporo 060-0807, JapanSapporo Diabetes and Thyroid Clinic, Sapporo 060-0807, JapanKurihara Clinic, Sapporo 004-0053, JapanKurihara Clinic, Sapporo 004-0053, JapanAoki Clinic, Sapporo 003-0023, JapanDepartment of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo 060-8638, JapanDepartment of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo 060-8638, JapanDepartment of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo 060-8638, JapanDepartment of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo 060-8638, JapanOral semaglutide has potent anti-hyperglycemic efficacy in phase III trials. However, the complicated dosing instructions hamper to use this drug; therefore, we evaluated the efficacy and safety of oral semaglutide in subjects with type 2 diabetes in a real-world clinical setting. In this multi-center retrospective observational study, we analyzed subjects with type 2 diabetes newly treated with an oral semaglutide for >6 months at four medical centers located in Sapporo, Japan. The changes in glycated hemoglobin, body weight, and other metabolic parameters were evaluated and any adverse event leading to semaglutide discontinuation were recorded from February 2021 to December 2022. This study was registered with the University Hospital Medical Information Network Center (UMIN000050583). Of 543 subjects who met the inclusion criteria, data for 434 subjects (age 55.5 ± 12.6 years; body mass index 29.6 ± 6.0 kg/m2) were analyzed. After a 6 months of observation period, semaglutide 3 mg, 7 mg, or 14 mg was used by 55 (12.7%), 241 (55.5%), and 138 (31.8%) of subjects, respectively. Both glycated hemoglobin and body weight significantly improved: 7.65 ± 1.11% to 6.88 ± 0.91% (p < 0.001) and 80.2 ± 19.2 kg to 77.6 ± 19.2 kg (p < 0.001), respectively. Efficacy was also confirmed in the subgroup switched from other anti-hyperglycemic agents, including dipeptidyl peptidase-4 inhibitors. In total, 154 subjects had symptomatic gastrointestinal symptoms and 39 (7.2%) were discontinued semaglutide due to the adverse events. None of the participants experienced severe hypoglycemic events. Oral semaglutide in subjects with type 2 diabetes improved glycemic control and body weight in a real-world clinical setting.https://www.jstage.jst.go.jp/article/endocrj/71/6/71_EJ23-0648/_html/-char/enclinical trialglucagon-like peptide-1 receptor agonistglycemic controltype 2 diabetes |
| spellingShingle | Sho Furusawa Hiroshi Nomoto Chiho Oba-Yamamoto Jun Takeuchi Miki Ito Hiroyoshi Kurihara Shin Aoki Aika Miya Hiraku Kameda Akinobu Nakamura Tatsuya Atsumi Real-world clinical evidence of oral semaglutide on metabolic abnormalities in subjects with type 2 diabetes: a multicenter retrospective observational study (the Sapporo-Oral SEMA study) Endocrine Journal clinical trial glucagon-like peptide-1 receptor agonist glycemic control type 2 diabetes |
| title | Real-world clinical evidence of oral semaglutide on metabolic abnormalities in subjects with type 2 diabetes: a multicenter retrospective observational study (the Sapporo-Oral SEMA study) |
| title_full | Real-world clinical evidence of oral semaglutide on metabolic abnormalities in subjects with type 2 diabetes: a multicenter retrospective observational study (the Sapporo-Oral SEMA study) |
| title_fullStr | Real-world clinical evidence of oral semaglutide on metabolic abnormalities in subjects with type 2 diabetes: a multicenter retrospective observational study (the Sapporo-Oral SEMA study) |
| title_full_unstemmed | Real-world clinical evidence of oral semaglutide on metabolic abnormalities in subjects with type 2 diabetes: a multicenter retrospective observational study (the Sapporo-Oral SEMA study) |
| title_short | Real-world clinical evidence of oral semaglutide on metabolic abnormalities in subjects with type 2 diabetes: a multicenter retrospective observational study (the Sapporo-Oral SEMA study) |
| title_sort | real world clinical evidence of oral semaglutide on metabolic abnormalities in subjects with type 2 diabetes a multicenter retrospective observational study the sapporo oral sema study |
| topic | clinical trial glucagon-like peptide-1 receptor agonist glycemic control type 2 diabetes |
| url | https://www.jstage.jst.go.jp/article/endocrj/71/6/71_EJ23-0648/_html/-char/en |
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