Evidence map›Paper›PMID 30552800›Full record

Observational studyDiabetes, obesity & metabolism2019

A comparative effectiveness study of degludec and insulin glargine 300 U/mL in insulin-naïve patients with type 2 diabetes.

Joseph Tibaldi, Martin Hadley-Brown, Andreas Liebl, Steffen Haldrup, Viktor Sandberg, Michael L Wolden, Helena W Rodbard

Registry-linked trialAbstract readComparative StudyObservational Study
In one paragraph

Observational study 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 NCT04692415 (The Differences Between Insulin Glargine U300 and Insulin Degludec U100 in Impact on the Glycaemic Variability, Oxidative Stress, Arterial Stiffness and the Lipid Profiles in Insulin naïve Patients Suffering From Type Two Diabetes Mellitus), which is not on this map. Cited by 27 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

NCT04692415 phase4completednot on this map

The Differences Between Insulin Glargine U300 and Insulin Degludec U100 in Impact on the Glycaemic Variability, Oxidative Stress, Arterial Stiffness and the Lipid Profiles in Insulin naïve Patients Suffering From Type Two Diabetes Mellitus

TypeinterventionalSponsorUniversity of Split, School of MedicineRan2018 to 2019Enrolled25ConditionsDiabetes Mellitus, Type 2ArmsDegludec, Glargine U300
3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Observational
  4. Review
  5. Article
  6. Article
  7. Article
  8. Article
  9. Observational
  10. 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
  11. Review
  12. Article
  13. Insulin doses requirements in patients with type 1 diabetes using glargine U300 or degludec in routine clinical practice.Journal of investigative medicine : the official publication of the American Federation for Clinical Research · 2021
    Article
  14. Review
  15. Article
  16. Review
  17. Understanding the Clinical Profile of Insulin Degludec, the Latest Basal Insulin Approved for Use in Canada: a Narrative Review.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2020
    Review
  18. Article
  19. Article
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors.

Joseph TibaldiFresh Meadows Diabetes and Endocrinology, New York, New York.ORCID 0000-0001-5449-1253
Martin Hadley-BrownSchool Lane Surgery, Thetford, Norfolk Primary Care Trust, Norfolk, UK.
Andreas LieblCentre for Diabetes and Metabolism, Fachklinik Bad Heilbrunn, Bad Heilbrunn, Germany.
Steffen HaldrupMarket Access, Novo Nordisk A/S, Søborg, Denmark.
Viktor SandbergMarket Access, Novo Nordisk A/S, Søborg, Denmark.
Michael L WoldenMarket Access, Novo Nordisk A/S, Søborg, Denmark.
Helena W RodbardClinical Research, Endocrine and Metabolic Consultants, Rockville, Maryland.ORCID 0000-0002-6187-8445

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsTo compare the real-world effectiveness of insulin degludec (degludec) and glargine 300 units/mL (glargine U300) in insulin-naïve adult patients with type 2 diabetes in routine US clinical practice. MATERIALS AND

methodsCONFIRM is a non-interventional comparative effectiveness study following US patients across the continuum of care, through electronic medical records from multiple health systems and integrated delivery networks. Propensity-score matching controlled for confounding. The primary endpoint, change in HbA1c from baseline to 180 days of follow-up, was estimated using a repeated-measure of covariance analysis with subject as random effect. Change in the rate of hypoglycaemic episodes (defined using International Classification of Diseases codes 9/10) and change in proportion of patients with hypoglycaemia were estimated using negative binomial and logistic regression, respectively. Time-to-discontinuation of the initial basal insulin/initiation with another prescribed basal insulin was analysed using a Cox Proportional Hazard model.

resultsData concerning 4056 patients were analysed. After matching, baseline characteristics were comparable (n = 2028 in each group). After 180 days of follow-up, degludec was associated with a larger reduction in HbA1c (estimated treatment difference, -0.27%; P = 0.03), greater reductions in change in rate (rate ratio, 0.70; P < 0.05) and greater reductions in change in the likelihood of hypoglycaemia (odds ratio, 0.64; P < 0.01]) compared with glargine U300. In addition, patients treated with degludec were 27% less likely to discontinue treatment at follow-up compared with those treated with glargine U300 (hazard ratio, 0.73; P < 0.001).

conclusionsSignificantly improved HbA1c, larger reductions in rates and likelihood of hypoglycaemia and lower risk of treatment discontinuation were demonstrated with degludec vs glargine U300.

Indexed as

AdultAgedBlood GlucoseComparative Effectiveness ResearchDiabetes Mellitus, Type 2Drug MonitoringFemaleGlycated HemoglobinHumansHypoglycemiaHypoglycemic AgentsInsulin GlargineInsulin, Long-ActingMaleMiddle AgedTreatment OutcomeBlood GlucoseGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic Agentsinsulin degludecInsulin GlargineInsulin, Long-Actingdatabase researchglycaemic controlhypoglycaemiainsulin analoguesobservational studytype 2 diabetes

Identifiers

PMID30552800
PMCPMC6590449

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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.