Evidence mapPaperPMID 39757952Full record

Observational studyDiabetes, obesity & metabolism2025

Effectiveness and safety of iGlarLixi in people with type 2 diabetes not at target on basal insulin and oral antidiabetic therapy in a prospective observational trial.

Jochen Seufert, Tobias Wiesner, Katrin Pegelow, Julia Kenzler, Martin Pfohl

Abstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Diabetes, obesity & metabolism, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Article
  2. Review
  3. Observational
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

5 authors.

Jochen SeufertDivision of Endocrinology and Diabetology, Department of Medicine II, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.ORCID 0000-0001-5654-7310
Tobias WiesnerMedical Care Center, Metabolic Medicine Leipzig, Leipzig, Germany.ORCID 0000-0002-6719-5223
Katrin PegelowSanofi-Aventis Deutschland GmbH, Berlin, Germany.ORCID 0000-0001-9002-5305
Julia KenzlerSanofi-Aventis Deutschland GmbH, Berlin, Germany.ORCID 0009-0001-8134-7588
Martin PfohlMedical Care Center Endocrinology and Diabetology, Düsseldorf, Germany.ORCID 0000-0002-6853-0302

Funding

Sanofi-Aventis Deutschland GmbH
6 · The paper itself

Abstract

aimsThis study assessed efficacy and safety of the fixed ratio combination iGlarLixi 100/33 (insulin glargine 100 U/mL plus lixisenatide 33 μg/mL) in people with type 2 diabetes (PwT2D) in daily clinical practice. MATERIALS AND

methodsThis non-interventional, multicentre, prospective, single-arm 24-week study documented PwT2D with an HbA1c of 7.5%-10.0%, currently treated with a basal insulin supported oral therapy (BOT) in German primary care facilities, after the physician had decided to change treatment to iGlarLixi 100/33, independent of study participation. Primary end-point was the absolute change in HbA1c (%) from baseline.

resultsOf 93 participants included, 70 comprised the full analysis set for efficacy assessment. Approximately 24 weeks after switching to iGlarLixi 100/33 HbA1c (mean ± standard deviation) changed from 8.52 ± 0.82% by -0.74 ± 0.81% to 7.74 ± 0.76%, FPG from 174.3 ± 44.6 mg/dL (9.67 ± 2.48 mmol/L) by -32.9 ± 46.3 mg/dL (-1.83 ± 2.57 mmol/L) to 141.4 ± 34.1 mg/dL (7.85 ± 1.89 mmol/L) and body weight from 104.3 ± 22.5 kg by -3.0 ± 7.5 kg to 101.3 ± 21.6 kg (all p < 0.01). Furthermore, use of DPP4 inhibitors was significantly reduced from 34.8% to 6.8% of participants. Derived (from 7-point self-measured plasma glucose) time in range (TIR) increased and time above range (TAR) decreased after 24 weeks to target ranges (all p < 0.05). Flash glucose monitoring data of 20 patients showed similar patterns for TIR and TAR, respectively, and a reduction in time below range (p = 0.007). Hypoglycaemia events did not change significantly and were low in number. No severe hypoglycaemia was reported.

conclusionsModifying antiglycaemic treatment from a BOT regimen to iGlarLixi 100/33 in suboptimal controlled PwT2D in daily clinical practice improved glycaemic control without increasing hypoglycaemia and with favourable body weight change.

Indexed as

Diabetes Mellitus, Type 2Hypoglycemic AgentsInsulin GlarginePeptidesAdministration, OralAgedBlood GlucoseDrug CombinationsDrug Therapy, CombinationFemaleGermanyGlucagon-Like Peptide-2 ReceptorGlycated HemoglobinHumansHypoglycemiaMaleBlood GlucoseDrug CombinationsGlucagon-Like Peptide-2 ReceptorGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsInsulin GlarginelixisenatidePeptidesfixed ratio combinationglycaemic controlhypoglycaemiaiGlarLixiobservational studytime in rangetype 2 diabetes

Identifiers

PMID39757952
PMCPMC11802399

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.