Evidence map›Paper›PMID 30160030›Full record

ArticleDiabetes, obesity & metabolism2019

A post-hoc pooled analysis to evaluate the risk of hypoglycaemia with insulin glargine 300 U/mL (Gla-300) versus 100 U/mL (Gla-100) over wider nocturnal windows in individuals with type 2 diabetes on a basal-only insulin regimen.

Geremia B Bolli, Carol Wysham, Miles Fisher, Soazig Chevalier, Anna M G Cali, Bruno Leroy, Matthew C Riddle

Abstract read
In one paragraph

Article in Diabetes, obesity & metabolism, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing 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.

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

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

  1. Pooled it
  2. Review
  3. Article
  4. 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.

Geremia B BolliDepartment of Medicine, University of Perugia, Perugia, Italy.ORCID 0000-0003-4966-4003
Carol WyshamDiabetes and Endocrinology Center, Rockwood Clinic, Spokane, Washington.
Miles FisherGlasgow Royal Infirmary, University of Glasgow, Glasgow, UK.
Soazig ChevalierSanofi, Paris, France.
Anna M G CaliSanofi, Paris, France.
Bruno LeroySanofi, Paris, France.
Matthew C RiddleOregon Health and Science University, Portland, Oregon.ORCID 0000-0003-1169-3036

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The EDITION trials in type 2 diabetes demonstrated comparable glycaemic control with less nocturnal and anytime (24-hour) hypoglycaemia for insulin glargine 300 U/mL (Gla-300) versus glargine 100 U/mL (Gla-100). However, the predefined nocturnal window (0:00-5:59 AM) may not be the most relevant for clinical practice. This post-hoc analysis compared expansions of the predefined nocturnal interval during basal insulin treatment without prandial insulin. Patient-level, 6-month data, pooled from the EDITION 2 and 3 trials and the EDITION JP 2 trial (N = 1922, basal insulin only) were analysed. Accompanying hypoglycaemia during treatment with Gla-300 was compared to that during treatment with Gla-100, using predefined (0:00-5:59 AM) and expanded (10:00 PM-5:59 AM, 0:00-7:59 AM, 10:00 PM to pre-breakfast SMPG) windows. Confirmed (≤3.9 mmol/L [≤70 mg/dL]) or severe hypoglycaemic events were reported most frequently between 6:00 AM and 8:00 AM. Windows expanded beyond 6:00 AM included more events than other windows. The percentage of participants with at least one event was lower with Gla-300 than Gla-100 in all windows examined. Expanding the nocturnal interval allows better assessment of the risk of hypoglycaemia associated with basal insulin. The risk of nocturnal hypoglycaemia was consistently lower with Gla-300 versus Gla-100 using all four windows.

Indexed as

AdultCircadian RhythmClinical Trials, Phase III as TopicDiabetes Mellitus, Type 2Dose-Response Relationship, DrugDrug Administration ScheduleDrug Therapy, CombinationFemaleHumansHypoglycemiaInsulinInsulin GlargineMaleMulticenter Studies as TopicRandomized Controlled Trials as TopicRetrospective StudiesInsulinInsulin Glarginebasal insulinhypoglycaemiatype 2 diabetes

Identifiers

PMID30160030
PMCPMC6586031

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Registered trials

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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.