Accepted for/Published in: JMIR Research Protocols
Date Submitted: Oct 11, 2021
Date Accepted: Mar 18, 2022
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SGLT2i agonist plus GLP-1 receptor COMBination therapy in type 2 diabetes: a renal (KIDney) endpoints real world study-(COMBi-KID Study).
ABSTRACT
Background:
Sodium-glucose co-transporter-2 inhibitor (SGLT2i)s and glucagon-like peptide-1 receptor agonist (GLP-1RA)s are both considered to be standard care in the management of glycaemia in type 2 diabetes. Recent trial evidence has indicated benefits on primary renal endpoints for individual drugs within each medication class. Despite potential benefits of combining SGLT2i and GLP-1RA for glycaemia management according to national/international guideline recommendations, there is currently limited data on renal endpoints for this drug combination.
Objective:
To assess the real-world effects of combining SGLT2i and GLP-1 RA therapies on renal end-points, glycaemic control and weight in people with type 2 diabetes currently treated with renin-angiotensin system (RAS) blockade medication.
Methods:
This retrospective cohort study will utilise electronic health records of people with type 2 diabetes registered with general practices covering over 15million people in England and Wales and included in the Oxford-Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) network. A propensity score matched cohort of new users of SGLT2is, GLP-1 RAs, and those prescribed SGLT2is and GLP-1 RAs in combination, will be identified. These will be matched on drug history, comorbidities and demographics. A repeated measures multilevel, linear regression analysis will be performed to compare mean change (from baseline) in estimated glomerular filtration rate (eGFR) at 12 and 24 months between those switched onto combined therapy and those prescribed monotherapy of SGLT2i or GLP-1 RA. Secondary end points will be albuminuria, serum creatinine, glycated haemoglobin, body mass index will be similarly assessed for change at follow up.
Results:
The study proposal was approved by the Medical Sciences Interdivisional Research Ethics Committee, University Oxford in August 2021 (R76885/RE001). The study is due to be commenced October 2021 and expected completion by March 2020
Conclusions:
The present study will be one of the first to assess the combination of SGLT2i and GLP-1RA therapy for type 2 diabetes management and renal effects as primary endpoint in type 2 diabetes from a real-world perspective.
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