Evidence mapPaperPMID 41395661Full record

Trial reportDiabetes, obesity & metabolism2026

Insulin therapy DE-intensificAtion with iGlarLixi: A phase 4, open-label, parallel-group randomised controlled trial.

Peter Novodvorský, Lenka Thieme, Ivana Laňková, Štěpánka Franková, Alica Veselá, Emil Záhumenský, Tomáš Edelsberger, Marie Löblová, Ondřej Žižka, Miroslav Vytasil and 5 more

Abstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase IV
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
field-weighted citation impact
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

1 citing paper in PubMed.

  1. Trial
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

15 authors.

Peter NovodvorskýDiabetes Centre, Institute for Clinical and Experimental Medicine (IKEM), Prague, Czech Republic.ORCID 0000-0002-3292-7586
Lenka ThiemeDiabetes Centre, Institute for Clinical and Experimental Medicine (IKEM), Prague, Czech Republic.
Ivana LaňkováDiabetes Centre, Institute for Clinical and Experimental Medicine (IKEM), Prague, Czech Republic.
Štěpánka FrankováDiabetes Centre, Institute for Clinical and Experimental Medicine (IKEM), Prague, Czech Republic.
Alica VeseláEDUMED s.r.o., Náchod, Czech Republic.
Emil ZáhumenskýInternal and Diabetology Clinic, Valašské Klobouky, Czech Republic.
Tomáš EdelsbergerPrivate Diabetology Clinic, Krnov, Czech Republic.
Marie LöblováDiaclinic s.r.o., České Budějovice, Czech Republic.
Ondřej ŽižkaDiabetes Centre, Institute for Clinical and Experimental Medicine (IKEM), Prague, Czech Republic.
Miroslav VytasilSanofi, Prague, Czech Republic.
Felipe LauandGeneral Medicines, Sanofi, Paris, France.
Mireille BonnemaireGeneral Medicines, Sanofi, Paris, France.
Filip HrubýDepartment of Data Science, IKEM, Prague, Czech Republic.
Miloš MrázDiabetes Centre, Institute for Clinical and Experimental Medicine (IKEM), Prague, Czech Republic.
Martin HaluzíkDiabetes Centre, Institute for Clinical and Experimental Medicine (IKEM), Prague, Czech Republic.ORCID 0000-0002-0201-6888

Funding

Sanofi
6 · The paper itself

Abstract

aimsTo evaluate the efficacy and safety of transitioning from multiple daily injections (MDIs) insulin regimen to once-daily, fixed-ratio combination of basal insulin analog glargine 100 U/mL and a glucagon-like peptide 1 receptor agonist lixisenatide (iGlarLixi) in people with type 2 diabetes (PwT2D). MATERIALS AND

methodsInsulin therapy DE-intensificAtion with iglarLixi was a five-centre, open-label, parallel-group, active comparator, phase IV randomised controlled trial with a 24-week active treatment period. Eligible PwT2D (age 18-80 years, HbA1c ≤9% [75 mmol/mol], total daily dose of insulin ≤0.8 IU/kg, and fasting C-peptide above the lower limit of normal) were randomised in a 1:1 fashion to iGlarLixi initiation or continuation with MDI regimen. The primary endpoint was the mean change in HbA1c from baseline to 24 weeks after randomisation between the two treatment groups.

resultsNinety individuals (n = 45 in both treatment groups), 71/91 (79.0%) male with mean (SD) age 66.2 (8.7) years, HbA1c 7.9 (1.0) % (62.8 [10.9] mmol/mol), diabetes duration 17.5 (8.7) years and body mass index (BMI) 33.6 (5.5) kg/m

conclusionsInsulin therapy simplification from MDI regimen to once-daily iGlarLixi is an efficient and safe treatment option for PwT2D.

Indexed as

Diabetes Mellitus, Type 2Hypoglycemic AgentsInsulin GlarginePeptidesAdolescentAdultAgedAged, 80 and overBlood GlucoseDrug Administration ScheduleFemaleGlucagon-Like Peptide-1 Receptor AgonistsGlucagon-Like Peptide-2 ReceptorGlycated HemoglobinHumansHypoglycemiaBlood GlucoseGlucagon-Like Peptide-1 Receptor AgonistsGlucagon-Like Peptide-2 ReceptorGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsInsulin GlarginelixisenatidePeptidesiGlarLixiinsulin therapy simplification (de‐intensification)multiple daily injections insulin regimen (MDI)randomised controlled trialtype 2 diabetes (T2D)

Identifiers

PMID41395661
PMCPMC12890759

What Socratic holds

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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.