ABSTRACT
INTRODUCTION:
Multiple daily
injection insulin regimen (MDI) represents the most intensive
insulin regimen used in the management of people with
type 2 diabetes (PwT2D). Its
efficacy regarding glycaemic control is counterbalanced by the increased
risk of hypoglycaemia, frequently observed tendency to
weight gain and necessity for frequent
glucose monitoring. Recent introduction of novel
antidiabetic medications with pleiotropic effects reaching far beyond the reduction of glycaemia (HbA1c), such as the
glucagon-like peptide 1 receptor agonist (
GLP-1 RA), has significantly widened the
therapeutic options available for management of T2D. Consequently, there is currently a substantial number of PwT2D for whom the MDI regimen was initiated at a
time when no other options were available. Yet, in present times, these individuals could benefit from simplified
insulin regimens ideally taking advantage of the beneficial effects of the novel classes of
antidiabetic medications. iGlarLixi (Suliqua®) is a once-daily fixed-ratio combination of basal
insulin analogue
glargine 100 U/ml and a
GLP-1 RA lixisenatide.
METHODS:
Insulin therapy DE-intensificAtion with iglarLixi (IDEAL) is a six-centre, open-label, parallel-group, active comparator, phase IV randomised controlled trial with a 24-week active
treatment period examining the
efficacy and
safety of MDI regimen de-intensification with once-daily
administration of iGlarLixi versus MDI regimen continuation in PwT2D on a backgroud
therapy with
metformin ±
sodium-
glucose cotransporter 2 inhibitor. PLANNED
OUTCOMES:
The primary objective is to compare the effects of MDI
therapy de-intensification with iGlarLixi versus MDI regimen continuation regarding glycaemic control (HbA1c).
Secondary objectives include detailed evaluation of the effects of MDI regimen de-intensification with iGlarLixi on glycaemic control using standardised
continuous glucose monitoring (CGM)
metrics and
self-
monitoring of
plasma glucose. Furthermore,
body weight and
body composition analysis,
quality of life and
safety profile are evaluated. TRIAL REGISTRATION ClinicalTrials.gov, identifier NCT04945070.
