Evidence mapPaperPMID 28862801Full record

SynthesisDiabetes, obesity & metabolism2018

Better glycaemic control and less hypoglycaemia with insulin glargine 300 U/mL vs glargine 100 U/mL: 1-year patient-level meta-analysis of the EDITION clinical studies in people with type 2 diabetes.

Robert Ritzel, Ronan Roussel, Andrea Giaccari, Jiten Vora, Claire Brulle-Wohlhueter, Hannele Yki-Järvinen

Abstract readMeta-AnalysisReview
In one paragraph

Synthesis in Diabetes, obesity & metabolism, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 34 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 2 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.

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

34 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
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  6. Article
  7. Observational
  8. [Injection therapy of diabetes].Wiener klinische Wochenschrift · 2023
    Article
  9. Article
  10. Review
  11. Observational
  12. Review
  13. Article
  14. Observational
  15. Article
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  17. Article
  18. Review
  19. 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
  20. Persistence with Basal Insulin and Frequency of Hypoglycemia Requiring Hospitalization in Patients with Type 2 Diabetes.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2020
    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

6 authors.

Robert RitzelDivision of Endocrinology and Diabetes, Klinikum Schwabing and Klinikum Bogenhausen, Städtisches Klinikum München GmbH, Munich, Germany.ORCID 0000-0001-5417-4135
Ronan RousselINSERM, U-1138, Centre de Recherche des Cordeliers, Paris, France.ORCID 0000-0003-2292-8363
Andrea GiaccariCenter for Endocrine and Metabolic Diseases, Fondazione Policlinico Gemelli, Università Cattolica del Sacro Cuore, Rome, Italy.
Jiten VoraDepartment of Endocrinology, Royal Liverpool University Hospital, Liverpool, UK.
Claire Brulle-WohlhueterDiabetes Division, Sanofi, Paris, France.
Hannele Yki-JärvinenDepartment of Medicine, University of Helsinki, Helsinki, Finland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsTo investigate the efficacy and safety of insulin glargine 300 U/mL (Gla-300) vs insulin glargine 100 U/mL (Gla-100) over 12 months in a patient-level meta-analysis, using data from the EDITION studies in people with type 2 diabetes (T2DM).

methodsEDITION 1, 2 and 3 were multicentre, randomized, open-label, 2-arm, parallel-group, treat-to-target phase IIIa studies. Similar study designs and endpoints enabled a meta-analysis to be conducted.

resultsReductions in glycated haemoglobin (HbA1c) were better sustained over 12 months with Gla-300 than with Gla-100 (least squares [LS] mean difference in change from baseline: -0.10 % [95% confidence interval {CI} -0.18 to -0.02] or -1.09 mmol/mol [95% CI -2.01 to -0.20]; P = .0174). Risk of confirmed (≤3.9 mmol/L) or severe hypoglycaemia was 15% lower with Gla-300 vs Gla-100 at night (relative risk 0.85 [95% CI 0.77-0.92]) and 6% lower at any time of day (relative risk 0.94 [95% CI 0.90-0.98]). Rates of hypoglycaemia were 18% lower with Gla-300 vs Gla-100 at night (rate ratio 0.82 [95% CI 0.67-0.99]), but comparable at any time of day. HbA1c <7.0 % without nocturnal hypoglycaemia was achieved by 24% more participants with Gla-300 than with Gla-100 (relative risk 1.24 [95% CI 1.03-1.50]). Severe hypoglycaemia was rare; in both treatment groups the incidence of events at any time of day was ≤3.6%, while rates were ≤0.08 events per participant-year.

conclusionsIn a broad population of people with T2DM over 12 months, use of Gla-300 provided more sustained glycaemic control and significantly lower hypoglycaemia risk at night and at any time of day compared with Gla-100.

Indexed as

Body WeightClinical Trials, Phase III as TopicDiabetes Mellitus, Type 2Glycated HemoglobinHumansHypoglycemiaHypoglycemic AgentsInsulin GlargineMulticenter Studies as TopicRandomized Controlled Trials as TopicTreatment OutcomeGlycated HemoglobinHypoglycemic AgentsInsulin Glargineglycaemic controlhypoglycaemiainsulin analoguesmeta-analysisphase III studytype 2 diabetes

Identifiers

PMID28862801
PMCPMC5836995

What Socratic holds

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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.