Abstract

Introduction

Participants in randomised controlled trials (trials) are generally younger and healthier than many individuals encountered in clinical practice. Consequently, the applicability of trial findings is often uncertain. To address this, results from trials can be calibrated to more representative data sources. In a network meta-analysis, using a novel approach which allows the inclusion of trials whether or not individual-level participant data (IPD) is available, we will calibrate trials for three drug classes (sodium glucose cotransporter 2 (SGLT2) inhibitors, glucagon-like peptide-1 (GLP1) receptor analogues and dipeptidyl peptidase-4 (DPP4) inhibitors) to the Scottish diabetes register.

Methods and analysis

Medline and EMBASE databases, the US clinical trials registry (clinicaltrials.gov) and the Chinese Clinical Trial Registry (chictr.org.cn) will be searched from 1 January 2002. Two independent reviewers will apply eligibility criteria to identify trials for inclusion. Included trials will be phase 3 or 4 trials of SGLT2 inhibitors, GLP1 receptor analogues or DPP4 inhibitors, with placebo or active comparators, in participants with type 2 diabetes, with at least one of glycaemic control, change in body weight or major adverse cardiovascular event as outcomes. Unregistered trials will be excluded.

We have identified a target population from the population-based Scottish diabetes register. The chosen cohort comprises people in Scotland with type 2 diabetes who either (1) require further treatment due to poor glycaemic control where any of the three drug classes may be suitable, or (2) who have adequate glycaemic control but are already on one of the three drug classes of interest or insulin.

Ethics and dissemination

Ethical approval for IPD use was obtained from the University of Glasgow MVLS College Ethics Committee (Project: 200160070). The Scottish diabetes register has approval from the Scottish A Research Ethics Committee (11/AL/0225) and operates with Public Benefit and Privacy Panel for Health and Social Care approval (1617-0147).

PROSPERO registration number

CRD42020184174.

Details

Title
Calibrating a network meta-analysis of diabetes trials of sodium glucose cotransporter 2 inhibitors, glucagon-like peptide-1 receptor analogues and dipeptidyl peptidase-4 inhibitors to a representative routine population: a systematic review protocol
Author
Butterly, Elaine 1   VIAFID ORCID Logo  ; Wei, Lili 1 ; Adler, Amanda I 2 ; Almazam, Saleh A M 1 ; Alsallumi, Khalid 1 ; Blackbourn, Luke A K 3 ; Dias, Sofia 4   VIAFID ORCID Logo  ; Hanlon, Peter 1   VIAFID ORCID Logo  ; Hughes, Katherine 5 ; Lewsey, Jim 1   VIAFID ORCID Logo  ; Lindsay, Robert 6 ; McGurnaghan, Stuart 3   VIAFID ORCID Logo  ; Petrie, John 6 ; Phillippo, David 7 ; Sattar, Naveed 8   VIAFID ORCID Logo  ; Tomlinson, Laurie A 9   VIAFID ORCID Logo  ; Welton, Nicky 7 ; Wild, Sarah 10 ; McAllister, David 1 

1  School of Health and Wellbeing, University of Glasgow, Glasgow, UK 
2  Diabetes Trials Unit, University of Oxford, Oxford, UK 
3  Institute of Genetics and Molecular Medicine, University of Edinburgh, Edinburgh, UK 
4  Centre for Reviews and Dissemination, University of York, York, Select State, UK 
5  Department of Diabetes, Glasgow Royal Infirmary, NHS Greater Glasgow and Clyde, Glasgow, Glasgow, UK 
6  University of Glasgow BHF Glasgow Cardiovascular Research Centre, Glasgow, Glasgow, UK 
7  Population Health Sciences, University of Bristol, Bristol, UK 
8  Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK 
9  Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK 
10  Public Health Sciences, University of Edinburgh, Edinburgh, UK 
First page
e066491
Section
Epidemiology
Publication year
2022
Publication date
2022
Publisher
BMJ Publishing Group LTD
e-ISSN
20446055
Source type
Scholarly Journal
Language of publication
English
DOI
https://doi.org/10.1136/bmjopen-2022-066491
ProQuest document ID
2729585269
Copyright
© 2022 Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ. https://creativecommons.org/licenses/by/4.0/ This 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/4.0/ . Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.