Evidence map›Paper›PMID 38653903›Full record

ArticleDiabetes therapy : research, treatment and education of diabetes and related disorders2024

The IDEAL (Insulin therapy DE-intensificAtion with iglarLixi) Randomised Controlled Trial-Study Design and Protocol.

Peter Novodvorský, Lenka Thieme, Ivana Laňková, Miloš Mráz, Zoltán J Taybani, Balázs Bótyik, Péter Stella, Miroslav Vytasil, Felipe Lauand, Mireille Bonnemaire and 1 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Diabetes therapy : research, treatment and education of diabetes and related disorders, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04945070 (INSULIN THERAPY DE-INTENSIFICATION WITH iGlarLixi), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.8field-weighted citation impact, top 14% 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.

NCT04945070 phase4unknown statusnot on this map

INSULIN THERAPY DE-INTENSIFICATION WITH iGlarLixi

TypeinterventionalSponsorInstitute for Clinical and Experimental MedicineRan2021 to 2023Enrolled96ConditionsType 2 Diabetes Treated With InsulinArmsIGlarLixi, MDI - Multiple dose insulin injection
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 5 citations in OpenAlex.

  1. Trial
  2. Article
  3. Review
  4. Review
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

11 authors at 6 institutions in 4 countries.

Peter NovodvorskýDiabetes Centre, Institute for Clinical and Experimental Medicine (IKEM), Vídeňská 1958, 140 21, Prague 4, Czech Republic.ORCID http://orcid.org/0000-0002-3292-7586
Lenka ThiemeDiabetes Centre, Institute for Clinical and Experimental Medicine (IKEM), Vídeňská 1958, 140 21, Prague 4, Czech Republic.
Ivana LaňkováDiabetes Centre, Institute for Clinical and Experimental Medicine (IKEM), Vídeňská 1958, 140 21, Prague 4, Czech Republic.
Miloš MrázDiabetes Centre, Institute for Clinical and Experimental Medicine (IKEM), Vídeňská 1958, 140 21, Prague 4, Czech Republic.
Zoltán J TaybaniFirst Department of Endocrinology, Dr. Réthy Pál Member Hospital, Békes County Central Hospital, Békéscsaba, Hungary.
Balázs BótyikFirst Department of Endocrinology, Dr. Réthy Pál Member Hospital, Békes County Central Hospital, Békéscsaba, Hungary.
Péter StellaSanofi Hungary, Budapest, Hungary.
Miroslav VytasilSanofi, Prague, Czech Republic.
Felipe LauandGeneral Medicines, Sanofi, Paris, France.
Mireille BonnemaireGeneral Medicines, Sanofi, Paris, France.
Martin HaluzíkDiabetes Centre, Institute for Clinical and Experimental Medicine (IKEM), Vídeňská 1958, 140 21, Prague 4, Czech Republic. halm@ikem.cz.ORCID http://orcid.org/0000-0002-0201-6888
Institute of Clinical and Experimental Medicine · CZBékés Megyei Központi Kórház · HUCharles University · CZSanofi (France) · FRSanofi (Czechia) · CZSanofi (Hungary) · HU

Funding

Sanofi This is an investigator-initiated study which is supported by Sanofi.
6 · The paper itself

Abstract

introductionMultiple daily injection insulin regimen (MDI) represents the most intensive insulin regimen used in the management of people with type 2 diabetes (PwT2D). Its efficacy regarding glycaemic control is counterbalanced by the increased risk of hypoglycaemia, frequently observed tendency to weight gain and necessity for frequent glucose monitoring. Recent introduction of novel antidiabetic medications with pleiotropic effects reaching far beyond the reduction of glycaemia (HbA1c), such as the glucagon-like peptide 1 receptor agonist (GLP-1 RA), has significantly widened the therapeutic options available for management of T2D. Consequently, there is currently a substantial number of PwT2D for whom the MDI regimen was initiated at a time when no other options were available. Yet, in present times, these individuals could benefit from simplified insulin regimens ideally taking advantage of the beneficial effects of the novel classes of antidiabetic medications. iGlarLixi (Suliqua

methodsInsulin therapy DE-intensificAtion with iglarLixi (IDEAL) is a six-centre, open-label, parallel-group, active comparator, phase IV randomised controlled trial with a 24-week active treatment period examining the efficacy and safety of MDI regimen de-intensification with once-daily administration of iGlarLixi versus MDI regimen continuation in PwT2D on a backgroud therapy with metformin ± sodium-glucose cotransporter 2 inhibitor. PLANNED OUTCOMES: The primary objective is to compare the effects of MDI therapy de-intensification with iGlarLixi versus MDI regimen continuation regarding glycaemic control (HbA1c). Secondary objectives include detailed evaluation of the effects of MDI regimen de-intensification with iGlarLixi on glycaemic control using standardised continuous glucose monitoring (CGM) metrics and self-monitoring of plasma glucose. Furthermore, body weight and body composition analysis, quality of life and safety profile are evaluated.

trial registrationClinicalTrials.gov, identifier NCT04945070.

Indexed as

Complex insulin therapy simplificationFixed-ratio combination of GLP-1 receptor agonist and basal insulin (FRC)Insulin glargine/lixisenatide (iGlarLixi)Insulin therapy de-intensificationIntensified insulin therapy (IIT)Multiple daily injections insulin regimen (MDI)Type 2 diabetes (T2D)

Identifiers

PMID38653903
PMCPMC11096133
OpenAlexW4395071908

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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 OpenQuestion graph.