Effects of Switching from Liraglutide or Dulaglutide to Subcutaneous Semaglutide on Glucose Metabolism and Treatment Satisfaction in Patients with Type 2 Diabetes: Protocol for a Multicenter, Prospective, Randomized, Open-Label, Blinded-Endpoint, Parallel-Group Comparison Study (The SWITCH-SEMA 1 Study)
| العنوان: | Effects of Switching from Liraglutide or Dulaglutide to Subcutaneous Semaglutide on Glucose Metabolism and Treatment Satisfaction in Patients with Type 2 Diabetes: Protocol for a Multicenter, Prospective, Randomized, Open-Label, Blinded-Endpoint, Parallel-Group Comparison Study (The SWITCH-SEMA 1 Study) |
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| المؤلفون: | Tatsuya Atsumi, Chiho Oba-Yamamoto, Shin Aoki, Shinji Taneda, Hiraku Kameda, Hideaki Miyoshi, Hiroshi Nomoto, Kyu Yong Cho, Yoshio Kurihara, Jun Takeuchi, Hiroki Yokoyama, Akinobu Nakamura, So Nagai, Yuka Takahashi |
| المصدر: | Diabetes Therapy |
| بيانات النشر: | Springer Science and Business Media LLC, 2021. |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | medicine.medical_specialty, Endocrinology, Diabetes and Metabolism, 030209 endocrinology & metabolism, 030204 cardiovascular system & hematology, Study Protocol, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Internal medicine, Type 2 diabetes mellitus, Internal Medicine, Clinical endpoint, Medicine, Glucagon-like peptide 1 receptor, Glycemic, Treatment satisfaction, business.industry, Liraglutide, Semaglutide, Clinical trial, chemistry, Glucagon-like peptide-1 receptor agonist, Dulaglutide, Glycated hemoglobin, business, medicine.drug |
| الوصف: | Introduction Glucagon-like peptide (GLP)-1 receptor agonists exert potent hypoglycemic effects in patients with type 2 diabetes (T2D) in a blood glucose concentration-dependent manner. Once-weekly subcutaneous administration of the GLP-1 receptor agonist semaglutide has beneficial effects on glycemic and body weight control, but it is currently unclear if semaglutide provides superior glycemic control compared to conventional GLP-1 receptor agonists in the Japanese population. We aim to compare the effects of once-weekly subcutaneous semaglutide with those of liraglutide or dulaglutide administration in Japanese patients with T2D. Methods This study is a multicenter, prospective, randomized, open-label, blinded-endpoint, parallel-group trial. In total, 100 participants with T2D who have been treated with liraglutide (0.9–1.8 mg/day in plan A) or dulaglutide (0.75 mg/week in plan B) for more than 12 weeks and have a glycated hemoglobin (HbA1c) level of 6.0–9.9% and a body mass index (BMI) of ≥ 22 kg/m2 will be randomized to either continue using their existing GLP-1 receptor agonist or switch to subcutaneous semaglutide once weekly for 24 weeks. Biochemical analysis, physical assessment, and a quality-of-life questionnaire (DTSQ) will be completed at baseline and at the end of the study. The primary endpoint is the effect of semaglutide on the change in HbA1c. The secondary endpoints are the mean changes in total DTSQ score, body mass, abdominal circumference, systolic and diastolic blood pressure, pulse rate, factors associated with improvement in HbA1c and secondary endpoints, side effects, and other laboratory parameters. Planned Outcomes The results of the study will provide useful information regarding the effects of switching to semaglutide from other GLP-1 receptor agonists on glycemic control in patients with T2D. Ethics and Dissemination The Hokkaido University Certified Review Board (CRB no. 1180001) has approved the protocol (no. 018-005). The results will be disseminated in peer-reviewed journals and at scientific conferences. Trial Registration UMIN000042369 in the University Hospital Medical Information Network (UMIN); jRCT1011200008 in the Japan Registry of Clinical Trials (jRCT); pre-results. |
| تدمد: | 1869-6961 1869-6953 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b2e36b1c29e0059821e32748eada4dbbTest https://doi.org/10.1007/s13300-020-00986-9Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....b2e36b1c29e0059821e32748eada4dbb |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 18696961 18696953 |
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