drugset / Trial / NCT04945070

INSULIN THERAPY DE-INTENSIFICATION WITH iGlarLixi

NCT04945070

RandomizedParallel-groupOpen-labelTreatment

Summary

Intensive insulin therapy using multiple daily injections (MDI) constitutes the most intense type of regimen in type 2 diabetes mellitus (T2D). Although highly effective in lowering blood glucose, it can also increase the risk of hypoglycemia, promote weight gain and cause significant treatment burden for the patients. As demonstrated by a number of clinical studies, overtreatment is a common and generally unrecognized problem in patients with T2D; nevertheless, medication de-escalation is still infrequent in everyday clinical practice. IGlarLixi is a once-daily fixed-ratio combination (FRC) of a basal insulin and a glucagon-like peptide-1 receptor agonist (GLP-1 RA), which can offer similar efficacy in glucose control with lower rates of hypoglycemia and smaller weight gain that basal insulin regimens. The aim of our randomised, controlled study is to examine prospectively the safety and efficacy of de-escalating MDI regimens to iGlarLixi in T2D adult patients.

Timeline

Start
2021-07
Primary completion
2023-01
Completion
2023-06

Drugs

EvaluationDrugModalityDoseRoute
Subject iGlarLixi Unknown