Evidence map›Paper›PMID 31984443›Full record

Trial reportDiabetologia2020

Risk of hypoglycaemia with insulin degludec versus insulin glargine U300 in insulin-treated patients with type 2 diabetes: the randomised, head-to-head CONCLUDE trial.

Athena Philis-Tsimikas, David C Klonoff, Kamlesh Khunti, Harpreet S Bajaj, Lawrence A Leiter, Melissa V Hansen, Lone N Troelsen, Steen Ladelund, Simon Heller, Thomas R Pieber and 1 more

Registry-linked trialOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Diabetologia, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03078478 (A Trial Comparing the Efficacy and Safety of Insulin Degludec and Insulin Glargine 300 Units/mL in Subjects With Type 2 Diabetes Mellitus Inadequately Treated With Basal Insulin With or Without Oral Antidiabetic Drugs), which is not on this map. Cited by 34 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 3 pooled it
8.2field-weighted citation impact, top 2% 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.

NCT03078478 phase3completednot on this map

A Trial Comparing the Efficacy and Safety of Insulin Degludec and Insulin Glargine 300 Units/mL in Subjects With Type 2 Diabetes Mellitus Inadequately Treated With Basal Insulin With or Without Oral Antidiabetic Drugs

TypeinterventionalSponsorNovo Nordisk A/SRan2017 to 2019Enrolled1,609ConditionsDiabetes, Diabetes Mellitus, Type 2ArmsInsulin degludec, Insulin glargine
3 · Its place in the literature

Who cites it

34 citing papers in PubMed, 3 syntheses or guidelines pooled it, 70 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Review
  6. Article
  7. Review
  8. Article
  9. Review
  10. Review
  11. Review
  12. Review
  13. Out of Sight, Out of Mind: A Call to Action for the Treatment of Hypoglycemia.Clinical diabetes : a publication of the American Diabetes Association · 2024
    Article
  14. Article
  15. Review
  16. Observational
  17. Clinical Use of Insulin Glargine 300 U/mL in Adults with Type 2 Diabetes: Hypothetical Case Studies.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2022
    Review
  18. Article
  19. Review
  20. One hundred years of insulin therapy.Nature reviews. Endocrinology · 2021
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 6 institutions in 5 countries.

Athena Philis-TsimikasScripps Whittier Diabetes Institute, 10140 Campus Point Drive, Suite 200, San Diego, CA, 92121, USA. Philis-Tsimikas.Athena@scrippshealth.org.ORCID http://orcid.org/0000-0002-3986-9630
David C KlonoffDiabetes Research Institute, Mills-Peninsula Medical Center, San Mateo, CA, USA.
Kamlesh KhuntiDiabetes Research Centre, University of Leicester, Leicester, UK.
Harpreet S BajajLMC Diabetes and Endocrinology, Brampton, ON, Canada.
Lawrence A LeiterLi Ka Shing Knowledge Institute, Division of Endocrinology & Metabolism, St Michael's Hospital, University of Toronto, Toronto, ON, Canada.
Melissa V HansenNovo Nordisk A/S, Søborg, Denmark.
Lone N TroelsenNovo Nordisk A/S, Søborg, Denmark.
Steen LadelundNovo Nordisk A/S, Søborg, Denmark.
Simon HellerAcademic Unit of Diabetes, Endocrinology and Metabolism, University of Sheffield, Sheffield, UK.
Thomas R PieberDivision of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Graz, Austria.
CONCLUDE Study Group
Novo Nordisk (Denmark) · DKMedical University of Graz · ATSt. Michael's Hospital · CAUniversity of Leicester · GBMills Peninsula Health Services · USScripps Whittier Diabetes Institute · US

Funding

New York Regional Center for Diabetes Translation Research - Translational Intervention Methodology CoreP30DK111022 · NIDDK · ALBERT EINSTEIN COLLEGE OF MEDICINE, INC · PI JEFFREY GONZALEZ · 2016 to 2026
$7.8M
NIDDK NIH HHS P30 DK111022
6 · The paper itself

Abstract

aims/hypothesisA head-to-head randomised trial was conducted to evaluate hypoglycaemia safety with insulin degludec 200 U/ml (degludec U200) and insulin glargine 300 U/ml (glargine U300) in individuals with type 2 diabetes treated with basal insulin.

methodsThis randomised (1:1), open-label, treat-to-target, multinational trial included individuals with type 2 diabetes, aged ≥18 years with HbA

resultsOf the 1609 randomised participants, 733 of 805 (91.1%) in the degludec U200 arm and 734 of 804 (91.3%) in the glargine U300 arm completed the trial (87.3% and 87.8% completed on treatment, respectively). Baseline characteristics were comparable between the two treatment arms. For the primary endpoint, the rate of overall symptomatic hypoglycaemia was not significantly lower with degludec U200 vs glargine U300 (rate ratio [RR] 0.88 [95% CI 0.73, 1.06]). As there was no significant difference between treatments for the primary endpoint, the confirmatory testing procedure for superiority was stopped. The pre-specified confirmatory secondary hypoglycaemia endpoints were analysed using pre-specified statistical models but were now considered exploratory. These endpoints showed a lower rate of nocturnal symptomatic hypoglycaemia (RR 0.63 [95% CI 0.48, 0.84]) and severe hypoglycaemia (RR 0.20 [95% CI 0.07, 0.57]) with degludec U200 vs glargine U300. CONCLUSIONS/

interpretationThere was no significant difference in the rate of overall symptomatic hypoglycaemia with degludec U200 vs glargine U300 in the maintenance period. The rates of nocturnal symptomatic and severe hypoglycaemia were nominally significantly lower with degludec U200 during the maintenance period compared with glargine U300.

trial registrationClinicalTrials.gov NCT03078478

fundingThis trial was funded by Novo Nordisk (Bagsvaerd, Denmark).

Indexed as

AgedBlood GlucoseDiabetes Mellitus, Type 2Dose-Response Relationship, DrugFemaleGlycated HemoglobinHumansHypoglycemiaInsulin GlargineInsulin, Long-ActingMaleMiddle AgedRisk FactorsTreatment OutcomeBlood GlucoseGlycated Hemoglobininsulin degludecInsulin GlargineInsulin, Long-ActingClinical scienceHypoglycaemiaInsulin degludecInsulin glargineInsulin therapy

Identifiers

PMID31984443
PMCPMC7054369
OpenAlexW3002620086

What OpenQuestion holds

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LicenceCC BY
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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 OpenQuestion graph.