Evidence map›Paper›PMID 31076415›Full record

Trial reportDiabetes care2019

Efficacy and Safety of Fast-Acting Insulin Aspart Compared With Insulin Aspart, Both in Combination With Insulin Degludec, in Children and Adolescents With Type 1 Diabetes: The onset 7 Trial.

Bruce W Bode, Violeta Iotova, Margarita Kovarenko, Lori M Laffel, Paturi V Rao, Srikanth Deenadayalan, Magnus Ekelund, Steffen Falgreen Larsen, Thomas Danne

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Diabetes care, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02670915 (Efficacy and Safety of Faster-acting Insulin Aspart Compared to NovoRapid® Both in Combination With Insulin Degludec in Children and Adolescents With Type 1 Diabetes), which is not on this map. Cited by 20 papers.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed
6.2field-weighted citation impact, top 3% 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.

NCT02670915 phase3completednot on this map

Efficacy and Safety of Faster-acting Insulin Aspart Compared to NovoRapid® Both in Combination With Insulin Degludec in Children and Adolescents With Type 1 Diabetes

TypeinterventionalSponsorNovo Nordisk A/SRan2016 to 2018Enrolled834ConditionsDiabetes, Diabetes Mellitus, Type 1ArmsFaster-acting insulin aspart, insulin aspart, insulin degludec
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 64 citations in OpenAlex.

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  20. Fast-Acting Insulin Aspart: The Rationale for a New Mealtime Insulin.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2019
    Review
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

9 authors at 7 institutions in 6 countries.

Bruce W BodeAtlanta Diabetes Associates, Atlanta, GA bbode001@gmail.com.ORCID 0000-0002-9998-055X
Violeta IotovaUniversity Hospital St. Marina, Medical University Varna, Varna, Bulgaria.
Margarita KovarenkoPediatric Department, Novosibirsk State Medical University of the Ministry of Health of the Russian Federation, Novosibirsk, Russia.
Lori M LaffelJoslin Diabetes Center, Harvard Medical School, Boston, MA.ORCID 0000-0002-9675-3001
Paturi V RaoDiabetes Research Society, Hyderabad, India.
Srikanth DeenadayalanNovo Nordisk A/S, Søborg, Denmark.
Magnus EkelundNovo Nordisk A/S, Søborg, Denmark.
Steffen Falgreen LarsenNovo Nordisk A/S, Søborg, Denmark.
Thomas DanneChildren's Hospital Auf der Bult, Hannover, Germany.ORCID 0000-0003-0773-6961
Novo Nordisk (Denmark) · DKAtlanta Diabetes Associates · USIndia Diabetes Research Foundation · INJoslin Diabetes Center · USKinderkrankenhaus auf der Bult · DENovosibirsk State Medical University · RUUniversity Hospital St. Marina · BG

Funding

SPECIAL ASSAY COREP30DK036836 · NIDDK · JOSLIN DIABETES CENTER · PI ROHIT N. KULKARNI · 1986 to 2026
$50.5M
NIDDK NIH HHS P30 DK036836
6 · The paper itself

Abstract

objectiveTo confirm efficacy and safety of fast-acting insulin aspart (faster aspart) versus insulin aspart (IAsp), both with basal insulin degludec, in a pediatric population with type 1 diabetes. RESEARCH DESIGN AND

methodsAfter a 12-week run-in, this treat-to-target, 26-week, multicenter trial randomized participants (1 to <18 years) to double-blind mealtime faster aspart (

resultsAt week 26, mealtime and postmeal faster aspart were noninferior to IAsp regarding change from baseline in HbA

conclusionsIn children and adolescents with type 1 diabetes, mealtime and postmeal faster aspart with insulin degludec provided effective glycemic control with no additional safety risks versus IAsp. Mealtime faster aspart provided superior HbA

Indexed as

AdolescentBlood GlucoseChildChild, PreschoolDiabetes Mellitus, Type 1Double-Blind MethodDrug Administration ScheduleDrug CombinationsDrug Therapy, CombinationFemaleGlycated HemoglobinHumansHypoglycemiaHypoglycemic AgentsInfantInsulin AspartBlood GlucoseDrug CombinationsGlycated HemoglobinHypoglycemic AgentsInsulin Aspartinsulin degludecinsulin degludec, insulin aspart drug combinationInsulin, Long-Acting

Identifiers

PMID31076415
PMCPMC6973646
OpenAlexW2944768911

What OpenQuestion holds

Textmetadata
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.