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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 st
| 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 st |
| Authors: | Nomoto, Hiroshi Browse this author →KAKEN DB | | Furusawa, Sho Browse this author | | Nakamura, Akinobu Browse this author | | Takeuchi, Jun Browse this author | | Nagai, So Browse this author | | Yokoyama, Hiroki Browse this author | | Sakuma, Ichiro Browse this author | | Taneda, Shinji Browse this author | | Kurihara, Yoshio Browse this author | | Aoki, Shin Browse this author | | Miya, Aika Browse this author | | Kameda, Hiraku Browse this author | | Cho, Kyu Yong Browse this author | | Atsumi, Tatsuya Browse this author | | Miyoshi, Hideaki Browse this author →KAKEN DB |
| Keywords: | dipeptidyl peptidase-4 inhibitor | | glucagon-like peptide-1 receptor agonist | | type 2 diabetes mellitus |
| Issue Date: | May-2022 |
| Publisher: | BMJ Publishing Group |
| Journal Title: | BMJ Open |
| Volume: | 12 |
| Issue: | 5 |
| Start Page: | e056885 |
| Publisher DOI: | 10.1136/bmjopen-2021-056885 |
| Abstract: | 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). |
| Type: | article |
| URI: | http://hdl.handle.net/2115/86297 |
| Appears in Collections: | 北海道大学病院 (Hokkaido University Hospital) > 雑誌発表論文等 (Peer-reviewed Journal Articles, etc)
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