Evidence mapPaperPMID 31282028Full record

Trial reportDiabetes, obesity & metabolism2019

Long-term efficacy and safety of combined insulin and glucagon-like peptide-1 therapy: Evidence from the LEADER trial.

Cees J Tack, Stephan Jacob, Cyrus Desouza, Stephen C Bain, John B Buse, Michael A Nauck, John R Petrie, Neil R Poulter, Richard E Pratley, Helen Vanya B K Stegmann and 4 more

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 3 pooled it
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

7 citing papers in PubMed, 3 syntheses or guidelines pooled it, 13 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Review
  7. 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

14 authors at 11 institutions in 6 countries.

Cees J TackRadboud University Medical Center Nijmegen, Nijmegen, the Netherlands.ORCID 0000-0003-0322-1653
Stephan JacobPraxis für Prävention und Therapie, Kardio Metabolisches Institut, Villingen-Schwenningen, Germany.
Cyrus DesouzaVeterans Affairs Medical Center, Omaha, Nebraska.
Stephen C BainSwansea University Medical School, Swansea, UK.ORCID 0000-0001-8519-4964
John B BuseUniversity of North Carolina School of Medicine, Chapel Hill, North Carolina.
Michael A NauckDiabetes Center Bochum-Hattingen, St Josef Hospital (Ruhr-Universität Bochum), Bochum, Germany.ORCID 0000-0002-5749-6954
John R PetrieInstitute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.
Neil R PoulterInternational Centre for Circulatory Health, Imperial College London, London, UK.
Richard E PratleyAdventHealth Translational Research Institute, Orlando, Florida.
Helen Vanya B K StegmannNovo Nordisk A/S, Søborg, Denmark.
Heidrun Bosch-TrabergNovo Nordisk A/S, Søborg, Denmark.
Elena StartsevaNovo Nordisk A/S, Søborg, Denmark.
Bernard ZinmanLunenfeld-Tanenbaum Research Institute, Mt. Sinai Hospital, University of Toronto, Toronto, Canada.ORCID 0000-0002-0041-1876
LEADER Publication Committee on behalf of the LEADER Trial Investigators
Novo Nordisk (Denmark) · DKLondon International Development Centre · GBNephrologisches Zentrum Villingen-Schwenningen · DERadboud University Nijmegen · NLSt. Josef-Hospital · DESwansea University · GBTranslational Research Institute for Metabolism and Diabetes · USUniversity of Glasgow · GBUniversity of North Carolina at Chapel Hill · USUniversity of Toronto · CAVeterans Health Administration · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimGlucagon-like peptide-1 receptor agonist (GLP-1RA) and insulin combination therapy is an effective treatment option for type 2 diabetes, but long-term data are lacking. The aim was to assess the long-term efficacy of the GLP-1RA liraglutide in subgroups by insulin use in the LEADER trial. MATERIALS AND

methodsLEADER assessed cardiovascular (CV) safety and efficacy of liraglutide (1.8 mg) versus placebo (plus standard of care therapy) in 9340 patients with type 2 diabetes and high risk of CV disease, for up to 5 years. We analyzed CV events, metabolic parameters and hypoglycaemia post hoc in three subgroups by baseline insulin use (basal-only insulin, other insulin or no insulin). Insulin was a non-random treatment allocation as part of standard of care therapy.

resultsAt baseline, 5171 (55%) patients were not receiving insulin, 3159 (34%) were receiving basal-only insulin and 1010 (11%) other insulins. Insulin users had a longer diabetes duration and slightly worse glycaemic control (HbA1c) than the no-insulin subgroup. Liraglutide reduced HbA1c and weight versus placebo in all three subgroups (P < .001), and severe hypoglycaemia rate in the basal-only insulin subgroup. The need for insulin was less with liraglutide. CV risk reduction with liraglutide was similar to the main trial results in the basal-only and no-insulin subgroups.

conclusionsIn patients on insulin, liraglutide improved glycaemic control, weight and need for insulin versus placebo, for at least 36 months with no increased risk of severe hypoglycaemia, while maintaining CV safety/efficacy, supporting the combination of liraglutide and insulin for management of type 2 diabetes.

Indexed as

Glucagon-Like Peptide-1 Receptor AgonistsAgedDiabetes Mellitus, Type 2FemaleGlycated HemoglobinHumansHypoglycemic AgentsInsulinLiraglutideMaleMiddle AgedGlucagon-Like Peptide-1 Receptor AgonistsGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsInsulinLiraglutideglucagon-like peptide-1 analogueinsulin analoguesinsulin therapyliraglutidetype 2 diabetes

Identifiers

PMID31282028
PMCPMC6852575
OpenAlexW2954546034

What Socratic holds

Texttitle and abstract
LicenceCC BY-NC
Read underepoch 390

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 Socratic graph.