Evidence map›Paper›PMID 32350009›Full record

ArticleBMJ open2020

Rationale and methodology for a European pooled analysis of postmarketing interventional and observational studies of insulin glargine 300 U/mL in diabetes: protocol of REALI project.

Nick Freemantle, Riccardo C Bonadonna, Pierre Gourdy, Didac Mauricio, Dirk Mueller-Wieland, Gregory Bigot, Alice Ciocca, Celine Mauquoi, Mélissa Rollot, Mireille Bonnemaire

Open access · goldAbstract read
In one paragraph

Article in BMJ open, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing 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

8 citing papers in PubMed, 11 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. Article
  5. Article
  6. Article
  7. Impact of Age on the Effectiveness and Safety of Insulin Glargine 300 U/mL: Results from the REALI European Pooled Data Analysis.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2021
    Article
  8. 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 6 countries.

Nick FreemantleInstitute of Clinical Trials and Methodology, University College London, London, UK nicholas.freemantle@ucl.ac.uk.
Riccardo C BonadonnaAzienda Ospedaliero-Universitaria di Parma, Parma, Emilia-Romagna, Italy.
Pierre GourdyUniversity Hospital Centre Toulouse Cardiovascular and Metabolic Medicine Section, Toulouse, Midi-Pyrénées, France.
Didac MauricioEndocrinology & Nutrition, Hospital Universitari Germans Trias i Pujol, Barcelona, Spain.ORCID 0000-0002-2868-0250
Dirk Mueller-WielandUniversity Hospital Aachen, Aachen, Nordrhein-Westfalen, Germany.
Gregory BigotIVIDATA, Paris, France.
Alice CioccaGlobal Diabetes, Sanofi SA, Paris, Île-de-France, France.
Celine MauquoiIDDI SA, Louvain-la-Neuve, Belgium.
Mélissa RollotQuinten, Paris, France.
Mireille BonnemaireGlobal Diabetes, Sanofi SA, Paris, Île-de-France, France.
Sanofi (France) · FRHospital de Sant Pau · ESInstitut des Arts de Diffusion · BEMRC Clinical Trials Unit at UCL · GBUniversitätsklinikum Aachen · DEUniversité Toulouse III - Paul Sabatier · FRUniversity of Parma · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionType 2 diabetes mellitus (T2DM) is a common and heterogeneous disease. Using advanced analytic approaches to explore real-world data may identify different disease characteristics, responses to treatment and progression patterns. Insulin glargine 300 units/mL (Gla-300) is a second-generation basal insulin analogue with preserved glucose-lowering efficacy but reduced risk of hypoglycaemia. The purpose of the REALI pooled analysis described in this paper is to advance the understanding of the effectiveness and real-world safety of Gla-300 based on a large European patient database of postmarketing interventional and observational studies. METHODS AND ANALYSIS: In the current round of pooling, REALI will include data from up to 10 000 subjects with diabetes mellitus (mostly T2DM) from 20 European countries. Outcomes of interest include change from baseline to week 24 in haemoglobin A ETHICS AND DISSEMINATION: The proposed study does not involve collection of primary data. Moreover, all individual study protocols were approved by independent local ethics committees, and all study participants provided written informed consent. Furthermore, patient data is deidentified before inclusion in the REALI database. Hence, there is no requirement for ethical approval. Results will be disseminated via peer-reviewed publications and presentations at international congresses as data are analysed.

Indexed as

AdultAgedBlood GlucoseData AnalysisDatabases, FactualDiabetes Mellitus, Type 2Disease ProgressionEuropeFastingGlycated HemoglobinHumansHypoglycemic AgentsInsulin GlargineMiddle AgedMultivariate AnalysisObservational Studies as TopicBlood GlucoseGlycated HemoglobinHypoglycemic AgentsInsulin Glargineclinical practiceEuropeinsulin glargine 300 units/mLpooled analysistype 2diabetes mellitus

Identifiers

PMID32350009
PMCPMC7213840
OpenAlexW3022089422

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

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.