Evidence mapPaperPMID 30850995Full record

Trial reportDiabetes, obesity & metabolism2019

Cardiovascular safety and lower severe hypoglycaemia of insulin degludec versus insulin glargine U100 in patients with type 2 diabetes aged 65 years or older: Results from DEVOTE (DEVOTE 7).

Richard E Pratley, Scott S Emerson, Edward Franek, Matthew P Gilbert, Steven P Marso, Darren K McGuire, Thomas R Pieber, Bernard Zinman, Charlotte T Hansen, Melissa V Hansen and 4 more

Registry-linked trialOpen 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. It is linked to trial NCT01959529 (A Trial Comparing Cardiovascular Safety of Insulin Degludec Versus Insulin Glargine in Subjects With Type 2 Diabetes at High Risk of Cardiovascular Events), which is not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
2.7field-weighted citation impact, top 9% 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.

NCT01959529 phase3completednot on this map

A Trial Comparing Cardiovascular Safety of Insulin Degludec Versus Insulin Glargine in Subjects With Type 2 Diabetes at High Risk of Cardiovascular Events

TypeinterventionalSponsorNovo Nordisk A/SRan2013 to 2016Enrolled7,637ConditionsDiabetes, Diabetes Mellitus, Type 2Armsinsulin degludec, insulin glargine
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 19 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Article
  6. Article
  7. Review
  8. Review
  9. Review
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 10 institutions in 5 countries.

Richard E PratleyAdventHealth Translational Research Institute for Metabolism and Diabetes, Orlando, Florida.ORCID 0000-0002-2912-1389
Scott S EmersonUniversity of Washington, Seattle, Washington.
Edward FranekMossakowski Clinical Research Centre, Polish Academy of Sciences, Warsaw, Poland.
Matthew P GilbertLarner College of Medicine at The University of Vermont, Burlington, Vermont.
Steven P MarsoHCA Midwest Health Heart and Vascular Institute, Kansas City, Missouri.
Darren K McGuireUniversity of Texas Southwestern Medical Center, Dallas, Texas.
Thomas R PieberMedical University of Graz, Graz, Austria.ORCID 0000-0003-3554-0405
Bernard ZinmanLunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada.ORCID 0000-0002-0041-1876
Charlotte T HansenNovo Nordisk A/S, Søborg, Denmark.
Melissa V HansenNovo Nordisk A/S, Søborg, Denmark.
Thomas MarkNovo Nordisk A/S, Søborg, Denmark.
Alan C MosesNovo Nordisk A/S, Søborg, Denmark.
John B BuseUniversity of North Carolina School of Medicine, Chapel Hill, North Carolina.
DEVOTE Study Group
Novo Nordisk (Denmark) · DKHCA Midwest Division · USMedical University of Graz · ATMossakowski Medical Research Institute, Polish Academy of Sciences · PLMount Sinai Hospital · CAThe University of Texas Southwestern Medical Center · USTranslational Research Institute for Metabolism and Diabetes · USUniversity of North Carolina at Chapel Hill · USUniversity of Vermont · USUniversity of Washington · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsThe aim of this study was to describe the risks of cardiovascular (CV) events and severe hypoglycaemia with insulin degludec (degludec) vs insulin glargine 100 units/mL (glargine U100) in patients with type 2 diabetes (T2D) aged 65 years or older. MATERIALS AND

methodsA total of 7637 patients in the DEVOTE trial, a treat-to-target, randomized, double-blind trial evaluating the CV safety of degludec vs glargine U100, were divided into three age groups (50-64 years, n = 3682; 65-74 years, n = 3136; ≥75 years, n = 819). Outcomes by overall age group and randomized treatment differences were analysed for major adverse cardiovascular events (MACE), all-cause mortality, severe hypoglycaemia and serious adverse events (SAEs).

resultsPatients with increasing age had higher risks of CV death, all-cause mortality and SAEs, and there were non-significant trends towards higher risks of MACE and severe hypoglycaemia. Treatment effects on the risk of MACE, all-cause mortality, severe hypoglycaemia and SAEs were consistent across age groups, based on the non-significant interactions between treatment and age with regard to these outcomes.

conclusionsThere were higher risks of CV death, all-cause mortality and SAEs, and trends towards higher risks of MACE and severe hypoglycaemia with increasing age after adjusting for baseline differences. The effects across age groups of degludec vs glargine U100 on MACE, all-cause mortality and severe hypoglycaemia were comparable, suggesting that the risk of MACE, as well as all-cause mortality, is similar and the risk of severe hypoglycaemia is lower with degludec regardless of age. Evidence is conclusive only until 74 years of age.

Indexed as

Cardiovascular DiseasesDiabetes Mellitus, Type 2HypoglycemiaHypoglycemic AgentsInsulin GlargineAgedFemaleHumansInsulin, Long-ActingMaleMiddle AgedHypoglycemic Agentsinsulin degludecInsulin GlargineInsulin, Long-Actingbasal insulincardiovascular diseasehypoglycaemiatype 2 diabetes

Identifiers

PMID30850995
PMCPMC6617815
OpenAlexW2921421880

What Socratic holds

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LicenceCC BY-NC
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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.