Evidence map›Paper›PMID 25929311›Full record

SynthesisDiabetes, obesity & metabolism2015

Patient-level meta-analysis of the EDITION 1, 2 and 3 studies: glycaemic control and hypoglycaemia with new insulin glargine 300 U/ml versus glargine 100 U/ml in people with type 2 diabetes.

R Ritzel, R Roussel, G B Bolli, L Vinet, C Brulle-Wohlhueter, S Glezer, H Yki-Järvinen

Registry-linked trialOpen access · hybridAbstract readMeta-Analysis
In one paragraph

Synthesis in Diabetes, obesity & metabolism, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03455985 (Effectiveness of a Diabetes Focused Discharge Order Set Among Poorly Controlled Hospitalized Patients Transitioning to Glargine U300 Insulin), which is not on this map. Cited by 102 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
102citing papers in PubMed, 5 pooled it
25.3field-weighted citation impact, top 1% 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.

NCT03455985 naterminatednot on this mapstarted 2018, after this paper: background citation

Effectiveness of a Diabetes Focused Discharge Order Set Among Poorly Controlled Hospitalized Patients Transitioning to Glargine U300 Insulin

TypeinterventionalSponsorOhio State UniversityRan2018 to 2020Enrolled158ConditionsDiabetes Mellitus, Type 2, Patient Discharge, Blood Glucose, Low, Blood Glucose, HighArmsDischarge Order Set (DOS), Enhanced Standard Care (ESC)
3 · Its place in the literature

Who cites it

102 citing papers in PubMed, 5 syntheses or guidelines pooled it, 232 citations in OpenAlex.

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  15. Insulin depot absorption modeling and pharmacokinetic simulation with insulin glargine 300 U/mL
.International journal of clinical pharmacology and therapeutics · 2019
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42 more citing papers are in PubMed but not listed here.

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 6 institutions in 4 countries.

R RitzelKlinikum Schwabing, Städtisches Klinikum München GmbH, Munich, Germany.
R RousselDiabetology Endocrinology Nutrition, DHU FIRE, Bichat Hospital, Assistance Publique Hôpitaux de Paris, Paris, France.
G B BolliDepartment of Medicine, University of Perugia, Perugia, Italy.
L VinetEXPERIS IT, Nanterre, France.
C Brulle-WohlhueterSanofi, Paris, France.
S GlezerSanofi, Paris, France.
H Yki-JärvinenDivision of Diabetes, Faculty of Medicine and Helsinki University Central Hospital, University of Helsinki, Helsinki, Finland.
Sanofi (France) · FRAssistance Publique – Hôpitaux de Paris · FRMünchen Klinik Schwabing · DEUniversité Paris Nanterre · FRUniversity of Helsinki · FIUniversity of Perugia · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsTo conduct a patient-level meta-analysis of the EDITION 1, 2 and 3 studies, which compared the efficacy and safety of new insulin glargine 300 U/ml (Gla-300) with insulin glargine 100 U/ml (Gla-100) in people with type 2 diabetes (T2DM) on basal and mealtime insulin, basal insulin and oral antihyperglycaemic drugs, or no prior insulin, respectively.

methodsThe EDITION studies were multicentre, randomized, open-label, parallel-group, phase IIIa studies, with similar designs and endpoints. A patient-level meta-analysis of the studies enabled these endpoints to be examined over 6 months in a large population with T2DM (Gla-300, n = 1247; Gla-100, n = 1249).

resultsNo significant study-by-treatment interactions across studies were found, enabling them to be pooled. The mean change in glycated haemoglobin was comparable for Gla-300 and Gla-100 [each -1.02 (standard error 0.03)%; least squares (LS) mean difference 0.00 (95% confidence interval (CI) -0.08 to 0.07)%]. Annualized rates of confirmed (≤3.9 mmol/l) or severe hypoglycaemia were lower with Gla-300 than with Gla-100 during the night (31% difference in rate ratio over 6 months) and at any time (24 h, 14% difference). Consistent reductions were observed in percentage of participants with ≥1 hypoglycaemic event. Severe hypoglycaemia at any time (24 h) was rare (Gla-300: 2.3%; Gla-100: 2.6%). Weight gain was low (<1 kg) in both groups, with less gain with Gla-300 [LS mean difference -0.28 kg (95% CI -0.55 to -0.01); p = 0.039]. Both treatments were well tolerated, with similar rates of adverse events.

conclusionGla-300 provides comparable glycaemic control to Gla-100 in a large population with a broad clinical spectrum of T2DM, with consistently less hypoglycaemia at any time of day and less nocturnal hypoglycaemia.

Indexed as

AdultAgedBlood GlucoseDiabetes Mellitus, Type 2Dose-Response Relationship, DrugFemaleGlycated HemoglobinHumansHypoglycemiaHypoglycemic AgentsInsulin GlargineMaleMiddle AgedRandomized Controlled Trials as TopicBlood GlucoseGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsInsulin Glarginebasal insulininsulin glargineinsulin therapy

Identifiers

PMID25929311
PMCPMC4676914
OpenAlexW1545770620

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.