Evidence mapPaperPMID 35717487Full record

ArticleDiabetes therapy : research, treatment and education of diabetes and related disorders2022

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

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

Open access · goldAbstract read
In one paragraph

Article in Diabetes therapy : research, treatment and education of diabetes and related disorders, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.0field-weighted citation impact, top 23% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 8 citations in OpenAlex.

  1. Article
  2. Use of IDegLira to Intensify, Simplify, and Increase Appropriateness of Type 2 Diabetes Therapy: A Real-Life Experience.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2024
    Article
  3. Economic Evaluation of Once-Weekly Insulin Icodec from Italian NHS Perspective.ClinicoEconomics and outcomes research : CEOR · 2024
    Article
  4. Simplification of Complex Insulin Regimens with IdegLira in People with Type 2 Diabetes: Literature Review and Clinical Recommendations.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2023
    Article
  5. Article
  6. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 7 institutions in 1 country.

Gian Paolo FadiniDivision of Metabolic Diseases, Department of Medicine, Padova Hospital, University of Padova, Padua, Italy. gianpaolo.fadini@unipd.it.ORCID http://orcid.org/0000-0002-6510-2097
Raffaella BuzzettiDepartment of Experimental Medicine, Sapienza University of Rome - Policlinico Umberto I Hospital, Rome, Italy.
Maria Rosa FittipaldiInternal Medicine Unit, San Francesco d'Assisi Hospital, Oliveto Citra, Salerno, Italy.
Ferruccio D'IncauCenter of Diabetology, S. Maria del Prato Hospital, Feltre, Belluno, Italy.
Andrea Da PortoDivision of Internal Medicine, Department of Medicine, University of Udine, Udine, Italy.
Angela GirelliDiabetes Care Unit, Spedali Civili Hospital, Brescia, Italy.
Lucia SimoniMediNeos Observational Research, IQVIA Company, Modena, Italy.
Giusi LastoriaDiabetes Medical Advisor, Novo Nordisk SpA, Rome, Italy.
Agostino ConsoliDepartment of Medicine and Aging Sciences, Centro Scienze Dell'Invecchiamento-Medicina Traslazionale (CeSI-MeT), University G. D'Annunzio, Chieti, Italy.
REX study group
University of Udine · ITAzienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · ITHospital of Prato · ITNovo Nordisk (Italy) · ITPoliclinico Umberto I · ITUniversity of Chieti-Pescara · ITUniversity of Padua · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionIDegLira 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).

methodsAdult 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.

resultsOf 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%).

conclusionsIdegLira 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.

Indexed as

Basal bolus therapy (BB)Basal insulin analogueBasal oral therapy (BOT)Glycated hemoglobin (HbA1c)IDegLiraOral antidiabetic drugs (OADs)Rapid insulin analogueReal-world evidenceType 2 diabetes

Identifiers

PMID35717487
PMCPMC9309107
OpenAlexW4283118962

What Socratic holds

Textmetadata
LicenceCC BY-NC
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.