IDegLira for the real-world treatment of type 2 diabetes in Italy. Final results from the REX observational study

Diabetes Obes Metab. 2024 May;26(5):1746-1756. doi: 10.1111/dom.15486. Epub 2024 Feb 8.

Abstract

Aim: The study was designed to generate real-world evidence on IDegLira in the Italian clinical practice in two groups of patients with type 2 diabetes (T2D), switching to IDegLira either from a basal only (basal group) or basal-bolus insulin regimen (BB group).

Materials and methods: This was a non-interventional, multicentre, single-cohort, prospective study assessing the long-term glycaemic control in patients with T2D, who switched to IDegLira from a basal insulin ± glucose-lowering medication regimen with or without a bolus insulin component for approximately 18 months, conducted in 28 Italian diabetes centres. The primary endpoint was the change in glycated haemoglobin (HbA1c) levels from baseline to 6 months after IDegLira initiation.

Results: The study included 358 patients with a mean age 67.2 years and diabetes duration of 15.7 years. HbA1c significantly decreased from IDegLira start to all study time points in the overall population (basal group -1.19%; BB group -0.60% at the end of observation). Patients achieving HbA1c <7% levels increased from 12.9% (n = 43) to 40.3% (n = 110) at 18 months. Fasting blood glucose and body weight also significantly decreased in both groups, although more in the BB group. Overall, 14.3% of completed patients had an intensification of treatment (mainly in the basal group) and 48.6% had a simplification of treatment (mainly in the BB group).

Conclusions: Switching to IDegLira in a real-world clinical setting is a valid therapeutic option for patients with T2D with inadequate glycaemic control on basal or BB insulin regimen and/or need to simplify their insulin therapy, with specific reasons and therapeutic goals according to different T2D management trajectories.

Keywords: basal insulin; glycaemic control; real‐world evidence; type 2 diabetes.

Publication types

  • Observational Study

MeSH terms

  • Aged
  • Blood Glucose
  • Diabetes Mellitus, Type 2* / drug therapy
  • Diabetes Mellitus, Type 2* / epidemiology
  • Drug Combinations
  • Glycated Hemoglobin
  • Humans
  • Hypoglycemic Agents / therapeutic use
  • Insulin / therapeutic use
  • Insulin, Long-Acting
  • Insulin, Regular, Human / therapeutic use
  • Italy / epidemiology
  • Liraglutide / therapeutic use
  • Prospective Studies

Substances

  • IDegLira
  • Hypoglycemic Agents
  • Glycated Hemoglobin
  • Blood Glucose
  • Insulin, Long-Acting
  • Liraglutide
  • Drug Combinations
  • Insulin
  • Insulin, Regular, Human

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