Trial reportDiabetes, obesity & metabolism2019

Health-related quality of life in people with type 2 diabetes participating in the LEADER trial.

Michael A Nauck, John B Buse, Johannes F E Mann, Stuart Pocock, Heidrun Bosch-Traberg, Helle Frimer-Larsen, Qing Ye, Alastair Gray, LEADER Publication Committee for the LEADER Trial Investigators

Registry-linked trialOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2019. The graph read 1 number from its abstract, feeding 1 cell of the map: it supports the treatment in 1. It reports registered trial NCT01179048. Cited by 20 papers, 3 of them syntheses that pooled it.

1number the graph read from it
1cell of the map it votes in
20citing papers in PubMed, 3 pooled it
2.0field-weighted citation impact, top 12% 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.

← favours the comparatorfavours the treatment →
0.040 · no effect
Quality of life & behaviourfavours the treatment · against placebo · t2dfeeds one cell of the map
Δ 0.020.00 to 0.04P = 0.020
RESULTS: At 36 months, less deterioration in EQ-5D utility index score was seen in the liraglutide group (-0.058) than in the placebo group (-0.082; estimated treatment difference [ETD] 0.023, 95% confidence interval [CI] 0.004;0.043; P = 0.020).

clause the extractor read what became the number

2 · Its place on the map

Where it lands on the map

Rows are treatments, columns are outcomes. The coloured squares are the cells this paper feeds, coloured by the vote it casts there. Click one to jump to what this paper adds to it.

supports the treatmentfavours the comparatorno clear differenceread, but no usable result
3 · What it changes

What it adds to each cell

For every cell the paper feeds: the belief in the claim with and without this paper, and this paper's estimate drawn against every other readable study in the cell. The ringed dot is this paper.

GLP-1 receptor agonists×quality of life & behaviour

SupportsOpen on the map →What to test next →

14 readable studies in this cell: 4 favour the treatment, 6 find no difference, 4 favour the comparator.

Belief with this paper
0.44contested · 4 families support, 5 contradict · against placebo
Without it
0.37This paper moves it by +0.07.
← favours the comparatorfavours the treatment →
0 · no effect
This paper · 2019
Δ 0.020.00 to 0.04
NCT017204463,297 enrolled · 2013
Δ 0.50-0.48 to 1.47
NCT039879191,879 enrolled · 2019
Δ -0.24-0.50 to 0.03
NCT02963935282 enrolled · 2017
Δ 0.16-1.19 to 1.52
NCT05564039282 enrolled · 2022
Δ 4.10-1.00 to 9.20
improved 2.001.52 to 5.98
NCT03951753117 enrolled · 2019
Δ -246-358 to -133
NCT04311411114 enrolled · 2020
Δ 6.63-1.53 to 14.8
NCT04019197108 enrolled · 2019
β coefficient 420-1012 to 1852
NCT0304179261 enrolled · 2017
Δ -236-322 to -149
weight loss -6.50-10.2 to -2.90
4 · 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.

NCT01179048 phase3completed

A Long-term, Multi-centre, International, Randomised Double-blind, Placebo-controlled Trial to Determine Liraglutide Effects on Cardiovascular Events

Ran2010Enrolled9,341Registered outcomes6Posted comparisons20ConditionsDiabetes, Diabetes Mellitus, Type 2Armsliraglutide, Placebo
Open the trial in the graph
5 · Its place in the literature

Who cites it

20 citing papers in PubMed, 3 syntheses or guidelines pooled it, 30 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Article
  9. The Long-Term Cost-Effectiveness of Oral Semaglutide Versus Lower-Cost Liraglutide in the UK.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2025
    Article
  10. Review
  11. Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. Article
  17. Review
  18. Article
  19. Article
  20. Article
6 · The record

Corrections and comments

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

7 · Who and what money

Authors and funding

9 authors at 6 institutions in 5 countries.

Michael A NauckDiabetes Centre Bochum-Hattingen, Medical Department I, St. Josef-Hospital, Ruhr-University, Bochum, Germany.ORCID 0000-0002-5749-6954
John B BuseDivision of Endocrinology, Department of Medicine, University of North Carolina School of Medicine, Chapel Hill, North Carolina.
Johannes F E MannKfH Kidney Centre, Munich, Germany.
Stuart PocockDepartment of Medical Statistics, Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.
Heidrun Bosch-TrabergNovo Nordisk, Bagsvaerd, Denmark.
Helle Frimer-LarsenNovo Nordisk, Bagsvaerd, Denmark.
Qing YeNovo Nordisk, Bagsvaerd, Denmark.
Alastair GrayNuffield Department of Population Health, Health Economics Research Centre, University of Oxford, Oxford, UK.
LEADER Publication Committee for the LEADER Trial Investigators
Novo Nordisk (Denmark) · DKFriedrich-Alexander-Universität Erlangen-Nürnberg · DELondon School of Hygiene & Tropical Medicine · GBSt. Josef-Hospital · DEUniversity of North Carolina at Chapel Hill · USUniversity of Oxford · GB

Funding

No grant is acknowledged in the PubMed record.

8 · The paper itself

Abstract

The marked sentences are the ones the graph read a number from.

aimsTo assess health-related quality of life (HRQoL) in people with type 2 diabetes (T2D) participating in the LEADER cardiovascular outcomes trial using the five-dimension European Quality of Life questionnaire (EQ-5D). MATERIALS AND

methodsThe EQ-5D was administered every 12 months in a subset of patients from Canada, Denmark, Germany, Ireland, Italy, Netherlands, Spain, Sweden, the United Kingdom and the United States. We compared changes in utility index scores and visual analogue scale (VAS) scores from baseline to 36 months in participants treated with liraglutide and placebo. We also assessed which complications had the greatest impact on quality of life.

resultsAt 36 months, less deterioration in EQ-5D utility index score was seen in the liraglutide group (-0.058) than in the placebo group (-0.082; estimated treatment difference [ETD] 0.023, 95% confidence interval [CI] 0.004;0.043; P = 0.020). A smaller decrease in EQ-5D VAS score was also demonstrated in the liraglutide group (-3.51) vs. the placebo group (-5.45; ETD 1.94, 95% CI 0.32;3.57; P = 0.019). The benefits of liraglutide treatment compared with placebo were driven primarily by shifts in the domains of mobility and self-care. The most influential events contributing to poorer HRQoL were stroke, heart failure, malignant neoplasm and confirmed hypoglycaemia.

conclusionsLiraglutide demonstrated a modest but significant benefit in patient-reported health status using the EQ-5D, compared with placebo. This benefit may be of clinical relevance and requires further study.

Indexed as

Quality of LifeAgedDiabetes Mellitus, Type 2Double-Blind MethodFemaleFollow-Up StudiesHealth StatusHumansInjections, SubcutaneousLiraglutideMaleMiddle AgedPatient Reported Outcome MeasuresPlacebosSelf CareSurveys and QuestionnairesLiraglutidePlacebosEQ-5Dhealth-related quality of lifeLEADERliraglutidepatient-reported outcomestype 2 diabetes

Identifiers

PMID30260088
PMCPMC6587748
OpenAlexW2893097539

What Socratic holds

Texttitle and abstract
LicenceCC BY-NC
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 Socratic graph.