دورية أكاديمية

TriMaster: randomised double-blind crossover study of a DPP4 inhibitor, SGLT2 inhibitor and thiazolidinedione as second-line or third-line therapy in patients with type 2 diabetes who have suboptimal glycaemic control on metformin treatment with or without a sulfonylurea - a MASTERMIND study protocol

التفاصيل البيبلوغرافية
العنوان: TriMaster: randomised double-blind crossover study of a DPP4 inhibitor, SGLT2 inhibitor and thiazolidinedione as second-line or third-line therapy in patients with type 2 diabetes who have suboptimal glycaemic control on metformin treatment with or without a sulfonylurea - a MASTERMIND study protocol
المؤلفون: Angwin, Catherine, Jenkinson, Caroline, Jones, Angus, Jennison, Christopher, Henley, William, Farmer, Andrew, Sattar, Naveed, Holman, Rury R., Pearson, Ewan, Shields, Beverley, Hattersley, Andrew
بيانات النشر: BMJ
سنة النشر: 2021
المجموعة: RD&E Research Repository (Royal Devon and Exeter NHS Foundation Trust)
الوصف: Introduction Pharmaceutical treatment options for patients with type 2 diabetes mellitus (T2DM) have increased to include multiple classes of oral glucose-lowering agents but without accompanying guidance on which of these may most benefit individual patients. Clinicians lack information for treatment intensification after first-line metformin therapy. Stratifying patients by simple clinical characteristics may improve care by targeting treatment options to those in whom they are most effective. This academically designed and run three-way crossover trial aims to test a stratification approach using three standard oral glucose-lowering agents. Methods and analysis TriMaster is a randomised, double-blind, crossover trial taking place at up to 25 clinical sites across England, Scotland and Wales. 520 patients with T2DM treated with either metformin alone, or metformin and a sulfonylurea who have glycated haemoglobin (HbA 1c ) >58 mmol/mol will be randomised to receive 16 weeks each of a dipeptidyl peptidase?4 inhibitor, sodium-glucose co-transporter-2 inhibitor and thiazolidinedione in random order. Participants will be assessed at the end of each treatment period, providing clinical and biochemical data, and their experience of side effects. Participant preference will be assessed on completion of all three treatments. The primary endpoint is HbA 1c after 4 months of therapy (allowing a range of 12-18 weeks for analysis). Secondary endpoints include participant-reported preference between the three treatments, tolerability and prevalence of side effects. Ethical approval This study was approved by National Health Service Health Research Authority Research Ethics Committee South Central-Oxford A, study 16/SC/0147. Written informed consent will be obtained from all participants. Results will be submitted to a peer-reviewed journal and presented at relevant scientific meetings. A lay summary of results will be made available to all participants. Trial registration numbers 12039221; 2015-002790-38 and NCT02653209. ...
نوع الوثيقة: article in journal/newspaper
اللغة: English
العلاقة: https://bmjopen.bmj.com/content/10/12/e042784Test; Angwin, C. et al. (2020) 'TriMaster: randomised double-blind crossover study of a DPP4 inhibitor, SGLT2 inhibitor and thiazolidinedione as second-line or third-line therapy in patients with type 2 diabetes who have suboptimal glycaemic control on metformin treatment with or without a sulfonylurea -a MASTERMIND study protocol', BMJ Open, 10(12), p. e042784. doi:10.1136/bmjopen-2020-042784.; https://rde.dspace-express.com/handle/11287/621836Test; BMJ Open
DOI: 10.1136/bmjopen-2020-042784
الإتاحة: https://doi.org/10.1136/bmjopen-2020-042784Test
https://rde.dspace-express.com/handle/11287/621836Test
حقوق: © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ. https://creativecommons.org/licenses/by/4.0/ThisTest is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0Test/. ; http://creativecommons.org/publicdomain/zero/1.0Test/
رقم الانضمام: edsbas.7790DC6B
قاعدة البيانات: BASE