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Diabetes Therapy
Published in: Diabetes Therapy 8/2022

Open Access 18-06-2022 | Insulins | Original Research

IDegLira for the Real-World Treatment of Type 2 Diabetes in Italy: Protocol and Interim Results from the REX Observational Study

Authors: Gian Paolo Fadini, Raffaella Buzzetti, Maria Rosa Fittipaldi, Ferruccio D’Incau, Andrea Da Porto, Angela Girelli, Lucia Simoni, Giusi Lastoria, Agostino Consoli, REX study group

Published in: Diabetes Therapy | Issue 8/2022

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Abstract

Introduction

IDegLira was shown to maintain glycemic control while reducing risk of hypoglycemia and body weight gain. The REX study was designed to generate real-world evidence on the use of IDegLira in Italian clinical practice in two different subgroups of patients, those switching to IDegLira from a basal insulin-supported oral therapy (BOT group) and those from a basal plus bolus insulin regimen (BB group).

Methods

Adult patients with T2D diagnosed for at least 12 months and having started IDegLira 2–3 months prior to enrolment, coming from a BOT or BB regimen, were enrolled in this multicenter observational prospective cohort study conducted in 28 Italian centers. This paper presents the methodological framework of the REX study and provides the interim analysis results describing the patients’ baseline characteristics and the clinical reasons for IDegLira treatment initiation.

Results

Of the 360 patients enrolled in the REX study, 331 were considered eligible for this interim analysis, 76.4% in the BOT and 23.6% in the BB group. Mean (SD) HbA1c was 8.5% (1.4) in the BOT and 8.2% (1.7) in the BB group. The most common T2D complications were diabetic macroangiopathy and diabetic nephropathy in both groups. The median (interquartile range) insulin daily dose before IDegLira was 15.0 (10.0–20.0) units in the BOT group and 42 (30.0–52.0) in the BB group. Oral antidiabetics were taken by 98% and 51.3% of patients, respectively. The main reason for switching to IDegLira was the inadequate glycemic control in the BOT group (86% of patients), and the intent to simplify the treatment in the BB group (66.7%).

Conclusions

IdegLira is initiated after BOT in inadequately controlled patients to improve glycemic control, whereas in BB patients it is used to simplify the therapeutic regimen. Final results of the REX study will shed light on patients’ outcomes after IdegLira treatment under routine clinical care.
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Metadata
Title
IDegLira for the Real-World Treatment of Type 2 Diabetes in Italy: Protocol and Interim Results from the REX Observational Study
Authors
Gian Paolo Fadini
Raffaella Buzzetti
Maria Rosa Fittipaldi
Ferruccio D’Incau
Andrea Da Porto
Angela Girelli
Lucia Simoni
Giusi Lastoria
Agostino Consoli
REX study group
Publication date
18-06-2022
Publisher
Springer Healthcare
Published in
Diabetes Therapy / Issue 8/2022
Print ISSN: 1869-6953
Electronic ISSN: 1869-6961
DOI
https://doi.org/10.1007/s13300-022-01287-z

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