Effects of switching from a dipeptidyl peptidase-4 inhibitor to oral semaglutide on glucose metabolism in patients with type 2 diabetes: protocol for a multicentre, prospective, randomised, open-label, parallel-group comparison study (the SWITCH-SEMA 2 study)
Introduction Incretin-based therapies exert antihyperglycaemic effects in patients with type 2 diabetes (T2D) in a blood glucose concentration-dependent fashion. The first-in-class oral glucagon-like peptide-1 receptor agonist semaglutide has potent effects on glycaemic and weight control, but littl...
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BMJ Publishing Group
2022-05-01
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| Online Access: | https://bmjopen.bmj.com/content/12/5/e056885.full |
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| author | Kyu Yong Cho Hiroki Yokoyama Tatsuya Atsumi Hiroshi Nomoto Jun Takeuchi So Nagai Yoshio Kurihara Shin Aoki Akinobu Nakamura Hideaki Miyoshi Shinji Taneda Ichiro Sakuma Sho Furusawa Aika Miya Hiraku Kameda |
| author_facet | Kyu Yong Cho Hiroki Yokoyama Tatsuya Atsumi Hiroshi Nomoto Jun Takeuchi So Nagai Yoshio Kurihara Shin Aoki Akinobu Nakamura Hideaki Miyoshi Shinji Taneda Ichiro Sakuma Sho Furusawa Aika Miya Hiraku Kameda |
| author_sort | Kyu Yong Cho |
| collection | DOAJ |
| description | Introduction Incretin-based therapies exert antihyperglycaemic effects in patients with type 2 diabetes (T2D) in a blood glucose concentration-dependent fashion. The first-in-class oral glucagon-like peptide-1 receptor agonist semaglutide has potent effects on glycaemic and weight control, but little evidence has been published for the superiority of semaglutide for glycaemic control in patients after switching from a dipeptidyl peptidase-4 (DPP-4) inhibitor. Therefore, we aim to verify the efficacy of oral semaglutide in patients with T2D being treated with a DPP-4 inhibitor.Methods and analysis This study is a multicentre, prospective, randomised, open-label, parallel-group trial. In total, 172 participants with T2D who have been treated with a DPP-4 inhibitor for more than 12 weeks and who have a glycated haemoglobin (HbA1c) level of 7.0%–9.9% will be randomised to continue using their existing DPP-4 inhibitor or switch to oral semaglutide for 24 weeks. Biochemical analyses and physical assessment will be performed, and adverse events will be recorded at baseline and at the end of the study. The primary endpoint will be the effect of oral semaglutide on the change in HbA1c. The secondary endpoints will be the mean changes in body weight, abdominal circumference, systolic and diastolic blood pressure (BP), pulse rate, the relationship between improvement of metabolic parameters including HbA1c and patient background characteristics, side effects and other laboratory parameters.Ethics and dissemination This will be the first study to compare the effects of switching from a DPP-4 inhibitor to oral semaglutide on glycaemic control in patients with T2D. The results will be disseminated in peer-reviewed journals and at scientific conferences. Hokkaido University Certified Review Board (CRB no.1180001) has approved the protocol (no. 020–013).Trial registration number UMIN000045270 in the University Hospital Medical Information Network; jRCT1011210032 in the Japan Registry of Clinical Trials. |
| format | Article |
| id | doaj-art-c71ac11459cd403d8e49e781e78fd724 |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-05-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-c71ac11459cd403d8e49e781e78fd7242025-08-20T02:17:08ZengBMJ Publishing GroupBMJ Open2044-60552022-05-0112510.1136/bmjopen-2021-056885Effects of switching from a dipeptidyl peptidase-4 inhibitor to oral semaglutide on glucose metabolism in patients with type 2 diabetes: protocol for a multicentre, prospective, randomised, open-label, parallel-group comparison study (the SWITCH-SEMA 2 study)Kyu Yong Cho0Hiroki Yokoyama1Tatsuya Atsumi2Hiroshi Nomoto3Jun Takeuchi4So Nagai5Yoshio Kurihara6Shin Aoki7Akinobu Nakamura8Hideaki Miyoshi9Shinji Taneda10Ichiro Sakuma11Sho Furusawa12Aika Miya13Hiraku Kameda14Clinical Research and Medical Innovation Center, Hokkaido University Hospital, Sapporo, JapanJiyugaoka Medical Clinic, Obihiro, Japan4 Department of Rheumatology, Endocrinology and Nephrology, Hokkaido University, Sapporo, JapanDepartment of Rheumatology, Endocrinology, and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, JapanSapporo Diabetes and Thyroid Clinic, Sapporo, JapanDivision of Diabetes and Endocrinology, Department of Medicine, NTT East Corporation, Sapporo, JapanKurihara Clinic, Sapporo, JapanAoki Clinic, Sapporo, JapanDepartment of Rheumatology, Endocrinology, and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, JapanDepartment of Rheumatology, Endocrinology, and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, JapanDiabetes Center, Manda Memorial Hospital, Sapporo, JapanCaress Sapporo Hokko Memorial Clinic, Sapporo, JapanDepartment of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Hokkaido, JapanDepartment of Rheumatology, Endocrinology, and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, JapanDepartment of Rheumatology, Endocrinology, and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, JapanIntroduction Incretin-based therapies exert antihyperglycaemic effects in patients with type 2 diabetes (T2D) in a blood glucose concentration-dependent fashion. The first-in-class oral glucagon-like peptide-1 receptor agonist semaglutide has potent effects on glycaemic and weight control, but little evidence has been published for the superiority of semaglutide for glycaemic control in patients after switching from a dipeptidyl peptidase-4 (DPP-4) inhibitor. Therefore, we aim to verify the efficacy of oral semaglutide in patients with T2D being treated with a DPP-4 inhibitor.Methods and analysis This study is a multicentre, prospective, randomised, open-label, parallel-group trial. In total, 172 participants with T2D who have been treated with a DPP-4 inhibitor for more than 12 weeks and who have a glycated haemoglobin (HbA1c) level of 7.0%–9.9% will be randomised to continue using their existing DPP-4 inhibitor or switch to oral semaglutide for 24 weeks. Biochemical analyses and physical assessment will be performed, and adverse events will be recorded at baseline and at the end of the study. The primary endpoint will be the effect of oral semaglutide on the change in HbA1c. The secondary endpoints will be the mean changes in body weight, abdominal circumference, systolic and diastolic blood pressure (BP), pulse rate, the relationship between improvement of metabolic parameters including HbA1c and patient background characteristics, side effects and other laboratory parameters.Ethics and dissemination This will be the first study to compare the effects of switching from a DPP-4 inhibitor to oral semaglutide on glycaemic control in patients with T2D. The results will be disseminated in peer-reviewed journals and at scientific conferences. Hokkaido University Certified Review Board (CRB no.1180001) has approved the protocol (no. 020–013).Trial registration number UMIN000045270 in the University Hospital Medical Information Network; jRCT1011210032 in the Japan Registry of Clinical Trials.https://bmjopen.bmj.com/content/12/5/e056885.full |
| spellingShingle | Kyu Yong Cho Hiroki Yokoyama Tatsuya Atsumi Hiroshi Nomoto Jun Takeuchi So Nagai Yoshio Kurihara Shin Aoki Akinobu Nakamura Hideaki Miyoshi Shinji Taneda Ichiro Sakuma Sho Furusawa Aika Miya Hiraku Kameda Effects of switching from a dipeptidyl peptidase-4 inhibitor to oral semaglutide on glucose metabolism in patients with type 2 diabetes: protocol for a multicentre, prospective, randomised, open-label, parallel-group comparison study (the SWITCH-SEMA 2 study) BMJ Open |
| title | Effects of switching from a dipeptidyl peptidase-4 inhibitor to oral semaglutide on glucose metabolism in patients with type 2 diabetes: protocol for a multicentre, prospective, randomised, open-label, parallel-group comparison study (the SWITCH-SEMA 2 study) |
| title_full | Effects of switching from a dipeptidyl peptidase-4 inhibitor to oral semaglutide on glucose metabolism in patients with type 2 diabetes: protocol for a multicentre, prospective, randomised, open-label, parallel-group comparison study (the SWITCH-SEMA 2 study) |
| title_fullStr | Effects of switching from a dipeptidyl peptidase-4 inhibitor to oral semaglutide on glucose metabolism in patients with type 2 diabetes: protocol for a multicentre, prospective, randomised, open-label, parallel-group comparison study (the SWITCH-SEMA 2 study) |
| title_full_unstemmed | Effects of switching from a dipeptidyl peptidase-4 inhibitor to oral semaglutide on glucose metabolism in patients with type 2 diabetes: protocol for a multicentre, prospective, randomised, open-label, parallel-group comparison study (the SWITCH-SEMA 2 study) |
| title_short | Effects of switching from a dipeptidyl peptidase-4 inhibitor to oral semaglutide on glucose metabolism in patients with type 2 diabetes: protocol for a multicentre, prospective, randomised, open-label, parallel-group comparison study (the SWITCH-SEMA 2 study) |
| title_sort | effects of switching from a dipeptidyl peptidase 4 inhibitor to oral semaglutide on glucose metabolism in patients with type 2 diabetes protocol for a multicentre prospective randomised open label parallel group comparison study the switch sema 2 study |
| url | https://bmjopen.bmj.com/content/12/5/e056885.full |
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