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

IntroductionParticipants 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 represent...

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Published in:	BMJ open Vol. 12; no. 10; p. e066491
Main Authors:	Butterly, Elaine, Wei, Lili, Adler, Amanda I, Almazam, Saleh A M, Alsallumi, Khalid, Blackbourn, Luke A K, Dias, Sofia, Hanlon, Peter, Hughes, Katherine, Lewsey, Jim, Lindsay, Robert, McGurnaghan, Stuart, Petrie, John, Phillippo, David, Sattar, Naveed, Tomlinson, Laurie A, Welton, Nicky, Wild, Sarah, McAllister, David
Format:	Journal Article
Language:	English
Published:	England British Medical Journal Publishing Group 27-10-2022 BMJ Publishing Group LTD BMJ Publishing Group
Series:	Protocol
Subjects:	Clinical trials Diabetes DIABETES & ENDOCRINOLOGY Diabetes Mellitus, Type 2 - chemically induced Diabetes Mellitus, Type 2 - drug therapy Dipeptidyl-Peptidase IV Inhibitors - therapeutic use Dipeptidyl-Peptidases and Tripeptidyl-Peptidases - therapeutic use Epidemiology Ethics Glucagon Glucagon-Like Peptide-1 Receptor Humans Hypoglycemic Agents - therapeutic use Inhibitor drugs Meta-analysis Meta-Analysis as Topic Network Meta-Analysis Peptides PUBLIC HEALTH Sodium-Glucose Transporter 2 Inhibitors - therapeutic use Systematic review Systematic Reviews as Topic PUBLIC HEALTH Clinical trials DIABETES & ENDOCRINOLOGY EPIDEMIOLOGY
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Summary:	IntroductionParticipants 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 analysisMedline 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 disseminationEthical 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 numberCRD42020184174.
Bibliography:	Protocol
ISSN:	2044-6055 2044-6055
DOI:	10.1136/bmjopen-2022-066491