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

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. Supplementary Information The online version contains supplementary material available at 10.1007/s13300-022-01287-z.

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

“…30 Furthermore, IDegLira has recently emerged as a valid and simple alternative to a complex BB insulin regimen for patients with T2D and poorly controlled diabetes, as documented by very high HbA1c (9%-15%). 31 The extent of HbA1c reductions in both groups of patients was consistent with that obtained in other Italian observational studies 21,22 and similar to that reported in the European retrospective study, 25 but also with the results of the randomized controlled trials of the DUAL programme. [7][8][9][10][11][12] In DUAL-V, patients on basal-only insulin randomized to IDegLira had a greater HbA1c reduction of 0.6% than those randomized to continuing and uptitrating basal insulin.…”

“…The baseline clinical characteristics of the study population were previously discussed in the interim results paper. 25 As expected, patients in the BB group were in a more advanced and complicated disease stage compared with those in the basal only group and had an average lower mean HbA1c but were still far from T A B L E 2 Patients with HbA1c <7% during the observation period in the overall population of evaluable patients and by patient groups. the target value of 7%.…”

“…The REX study had a special focus on two different groups of patients: those who intensified their regimen with basal‐only insulin and those who were stepping back from more complex BB regimens. The baseline clinical characteristics of the study population were previously discussed in the interim results paper 25 . As expected, patients in the BB group were in a more advanced and complicated disease stage compared with those in the basal only group and had an average lower mean HbA1c but were still far from the target value of 7%.…”

“…The study consisted of both primary data collection (during an 18‐month prospective observation period after the enrolment visit) and secondary use of pre‐existing data (during the retrospective observation period), from IDegLira initiation to the enrolment visit. The results of the retrospective part have been published before, along with the study protocol 25 . Patients were eligible if they had started IDegLira according to label indications before the enrolment visit, regardless of the physician's willingness to enrol the patient and the patient's decision to participate in the study.…”

Initiation of the Fixed Combination IDegLira in Patients with Type 2 Diabetes on Prior Injectable Therapy: Insights from the EASY French Real-World Study

“…This included the incidence of hypoglycemia which is more specifically expected to be lowered by switching from MDI to IDegLira. The ongoing prospective real-life studies, such as the Italian multicenter REX study [ 24 ], will probably provide more relevant observations on this important issue. Finally, the growing use of weekly GLP-1RAs, due to reduced frequency of administration and to increased potency in terms of glycemic and weight control, could call into question the relevance of our data for current clinical practice.…”