Evidence map›Paper›PMID 32515543›Full record

SynthesisDiabetes, obesity & metabolism2020

Lower risk of severe hypoglycaemia with insulin glargine 300 U/mL versus glargine 100 U/mL in participants with type 1 diabetes: A meta-analysis of 6-month phase 3 clinical trials.

Thomas Danne, Munehide Matsuhisa, Christian Sussebach, Harmonie Goyeau, Felipe Lauand, Elisabeth Niemoeller, Geremia B Bolli

Open access · hybridAbstract readMeta-Analysis
In one paragraph

Synthesis in Diabetes, obesity & metabolism, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 2 pooled it
2.4field-weighted citation impact, top 10% 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

19 citing papers in PubMed, 2 syntheses or guidelines pooled it, 24 citations in OpenAlex.

  1. American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update.Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists · 2022
    Guideline
  2. Pooled it
  3. Trial
  4. Review
  5. Article
  6. Review
  7. Review
  8. Safety and Effectiveness of Glargine 300 U/ml After Switching from Basal Insulins in Patients with Type 1 Diabetes: COMET-T Study.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2025
    Article
  9. Review
  10. Review
  11. Review
  12. Review
  13. Significance of Glycemic Variability in Diabetes Mellitus.Internal medicine (Tokyo, Japan) · 2022
    Article
  14. Article
  15. One hundred years of insulin therapy.Nature reviews. Endocrinology · 2021
    Review
  16. Review
  17. Article
  18. Article
  19. 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

7 authors at 5 institutions in 4 countries.

Thomas DanneChildren's Hospital Auf der Bult, Hannover Medical School, Hannover, Germany.ORCID 0000-0002-8424-3944
Munehide MatsuhisaDiabetes Therapeutics and Research Center, Institute of Advanced Medical Sciences, Tokushima University, Tokushima, Japan.
Christian SussebachSanofi, Frankfurt am Main, Germany.
Harmonie GoyeauSanofi, Chilly-Mazarin, France.
Felipe LauandSanofi, Paris, France.
Elisabeth NiemoellerSanofi, Frankfurt am Main, Germany.
Geremia B BolliSection of Endocrinology and Metabolism, Department of Medicine, Perugia University Medical School, Perugia, Italy.ORCID 0000-0003-4966-4003
Sanofi (France) · FRSanofi (Germany) · DEMedizinische Hochschule Hannover · DETokushima University · JPUniversity of Perugia · IT

Funding

The meta-analysis and clinical trials considered in the analysis were sponsored by Sanofi, Paris, France. Editorial and writing assistance was provided by Jennina Taylor-Wells, PhD, of Fishawack Communications Ltd., UK, and was funded by Sanofi.
6 · The paper itself

Abstract

Severe hypoglycaemia (SH) remains a challenge to people with type 1 diabetes (T1DM), and new-generation basal insulins may improve patient outcomes. This post hoc meta-analysis explored the risk of SH with insulin glargine 300 U/mL (Gla-300) versus glargine 100 U/mL (Gla-100) in a pooled population with T1DM from three randomized, multicentre, 6-month similarly designed phase 3 trials: EDITION 4, EDITION JP 1 and EDITION JUNIOR. Endpoints included incidence and time to first occurrence of SH. Among 629 and 626 participants randomized to Gla-300 and Gla-100, respectively, glycated haemoglobin reductions were similar. Fewer participants experienced ≥1 SH event with Gla-300 (6.2%) than with Gla-100 (9.3%). From baseline to month 6, the risk of a first SH event was lower with Gla-300: hazard ratio 0.65 [95% confidence interval (CI) 0.44-0.98; stratified log-rank test P = 0.038]. SH event rates were numerically lower with Gla-300 versus Gla-100 from baseline to month 6 [relative risk (RR) 0.80 (95% CI 0.49-1.29); P = 0.356] and baseline to week 8 [RR 0.73 (95% CI 0.37-1.44); P = 0.369]. Thus, Gla-300 demonstrated similar glycaemic control with lower risk of SH versus Gla-100, particularly during the titration period.

Indexed as

Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2HyperglycemiaHypoglycemiaDose-Response Relationship, DrugGlycated HemoglobinHumansHypoglycemic AgentsInsulin GlargineRiskGlycated HemoglobinHypoglycemic AgentsInsulin Glarginebasal insulinglycaemic controlhypoglycaemiainsulin analoguesmeta-analysistype 1 diabetes

Identifiers

PMID32515543
PMCPMC7540568
OpenAlexW3032938240

What OpenQuestion holds

Textmetadata
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 OpenQuestion graph.