NCT04945070

INSULIN THERAPY DE-INTENSIFICATION WITH iGlarLixi

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Institute for Clinical and Experimental Medicine · Other Government
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 2 Diabetes Treated With Insulin

Interventions

Type	Name	Description
DRUG	IGlarLixi	Switching T2DM subjects from MDI to iGlarLixi
DRUG	MDI - Multiple dose insulin injection	Continuing with established MDI regimen

Timeline

• Start date: 2021-07-01
• Primary completion: 2023-01-01
• Completion: 2023-06-01
• First posted: 2021-06-30
• Last updated: 2021-07-22

Locations

1 site across 1 country: Czechia