The IDEAL (Insulin therapy DE-intensificAtion with iglarLixi) Randomised Controlled Trial-Study Design and Protocol.
Complex insulin therapy simplification
Fixed-ratio combination of GLP-1 receptor agonist and basal insulin (FRC)
Insulin glargine/lixisenatide (iGlarLixi)
Insulin therapy de-intensification
Intensified insulin therapy (IIT)
Multiple daily injections insulin regimen (MDI)
Type 2 diabetes (T2D)
Journal
Diabetes therapy : research, treatment and education of diabetes and related disorders
ISSN: 1869-6953
Titre abrégé: Diabetes Ther
Pays: United States
ID NLM: 101539025
Informations de publication
Date de publication:
24 Apr 2024
24 Apr 2024
Historique:
received:
08
03
2024
accepted:
02
04
2024
medline:
24
4
2024
pubmed:
24
4
2024
entrez:
23
4
2024
Statut:
aheadofprint
Résumé
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 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. 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. ClinicalTrials.gov, identifier NCT04945070.
Identifiants
pubmed: 38653903
doi: 10.1007/s13300-024-01582-x
pii: 10.1007/s13300-024-01582-x
doi:
Banques de données
ClinicalTrials.gov
['NCT04945070']
Types de publication
Journal Article
Langues
eng
Subventions
Organisme : Sanofi
ID : This is an investigator-initiated study which is supported by Sanofi.
Informations de copyright
© 2024. The Author(s).
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