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Effects of switching from a dipeptidyl peptidase-4 inhibitor to luseogliflozin on nocturnal blood pressure in patients with type 2 diabetes : protocol for a multicentre, prospective, randomised, open-label, blinded endpoint parallel-group comparison study

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Title: Effects of switching from a dipeptidyl peptidase-4 inhibitor to luseogliflozin on nocturnal blood pressure in patients with type 2 diabetes : protocol for a multicentre, prospective, randomised, open-label, blinded endpoint parallel-group comparison study
Authors: Kameda, Reina Browse this author
Nomoto, Hiroshi Browse this author
Cho, Kyu Yong Browse this author
Kawata, Shinichiro Browse this author
Omori, Kazuno Browse this author
Takeuchi, Jun Browse this author
Nagai, So Browse this author →KAKEN DB
Kurihara, Yoshio Browse this author
Aoki, Shin Browse this author
Nakamura, Akinobu Browse this author →KAKEN DB
Atsumi, Tatsuya Browse this author →KAKEN DB
Miyoshi, Hideaki Browse this author →KAKEN DB
Issue Date: Feb-2020
Publisher: BMJ Publishing Group
Journal Title: BMJ Open
Volume: 10
Issue: 2
Start Page: e034883
Publisher DOI: 10.1136/bmjopen-2019-034883
Abstract: Introduction Nocturnal hypertension is clinically important for patients with type 2 diabetes (T2D), considering its strong correlation with cardiovascular events. We aim to test the hypothesis that the sodium-glucose cotransporter 2 inhibitor, luseogliflozin, ameliorates nocturnal hypertension more effectively than a dipeptidyl peptidase (DPP)-4 inhibitor in patients with T2D. Methods and analysis This study is a multicentre, prospective, randomised, open-label, blinded endpoint parallel-group trial. Sixty participants with T2D and hypertension who have been treated with a DPP-4 inhibitor for more than 4 weeks and who have a glycated haemoglobin A1c (HbA1c) level of 6.0%-9.0% will be randomised based on age, body mass index (BMI) and HbA1c to continue taking their DPP-4 inhibitor or to switch to luseogliflozin 2.5 mg once daily for 8 weeks. Twenty-four-hour ambulatory blood pressure monitoring (ABPM) will be performed twice at baseline and at the end of the study. All participants will continue their diet and exercise therapy, and the doses of concomitant medications will not be adjusted during the study. The primary endpoint is the effect of luseogliflozin on the mean change in systolic blood pressure (SBP) during the night, as measured by ABPM. The secondary endpoints are mean change in diastolic blood pressure (DBP) during the night, 24 hours of SBP and DBP, daytime SBP and DBP, pulse rate, BP M-value, trough SBP and DBP for 1 hour before the next dose, and other laboratory parameters. The sample size was calculated for a two-sided test at 90% power for the detection of a difference between treatments. Ethics and dissemination The Ethics Review Board of Hokkaido University Hospital has approved the protocol. The results will be disseminated in peer-reviewed journals and at scientific conferences.
Rights: http://creativecommons.org/licenses/by-nc/4.0/
Type: article
URI: http://hdl.handle.net/2115/78557
Appears in Collections:医学院・医学研究院 (Graduate School of Medicine / Faculty of Medicine) > 雑誌発表論文等 (Peer-reviewed Journal Articles, etc)

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