Evidence map›Paper›PMID 32306477›Full record

Trial reportPediatric diabetes2020

The association between anti-insulin aspart antibodies and the pharmacokinetic and pharmacodynamic characteristics of fast-acting insulin aspart in children and adolescents with type 1 diabetes.

Torben Biester, Thekla von dem Berge, Line Quist Bendtsen, Mette Dahl Bendtsen, Naveen Rathor, Thomas Danne, Hanne Haahr

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Pediatric diabetes, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.4field-weighted citation impact, top 36% 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

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Trial
  2. Review
  3. 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 3 institutions in 3 countries.

Torben BiesterDiabetes Centre for Children and Adolescents, Kinder- und Jugendkrankenhaus AUF DER BULT, Hannover, Germany.
Thekla von dem BergeDiabetes Centre for Children and Adolescents, Kinder- und Jugendkrankenhaus AUF DER BULT, Hannover, Germany.
Line Quist BendtsenClinical Pharmacology, Novo Nordisk A/S, Søborg, Denmark.
Mette Dahl BendtsenBiostatistics, Novo Nordisk A/S, Aalborg Ø, Denmark.
Naveen RathorGlobal Medical Affairs, Novo Nordisk Service Centre India Private Ltd., Bangalore, India.
Thomas DanneDiabetes Centre for Children and Adolescents, Kinder- und Jugendkrankenhaus AUF DER BULT, Hannover, Germany.ORCID 0000-0002-8424-3944
Hanne HaahrClinical Pharmacology, Novo Nordisk A/S, Søborg, Denmark.
Kinderkrankenhaus auf der Bult · DENovo Nordisk (Denmark) · DKNovo Nordisk (India) · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFast-acting insulin aspart (faster aspart) is a novel formulation of insulin aspart (IAsp) ensuring ultrafast absorption and effect.

aimTo compare the pharmacokinetics between faster aspart and IAsp, based on free or total IAsp measurement, and investigate the association between anti-IAsp antibodies and faster aspart and IAsp pharmacological properties in children and adolescents with type 1 diabetes (T1D).

methodsIn a randomized, two-period crossover trial, 12 children, 16 adolescents, and 15 adults (6-11, 12-17, and 18-64 years) received 0.2 U/kg double-blindsingle-dose subcutaneous faster aspart or IAsp followed by a standardized liquid meal test.

resultsAcross age groups, the pharmacokinetic profile was left-shifted including greater early exposure for faster aspart vs IAsp irrespective of free or total IAsp assay. Onset of appearance occurred 2.4 to 5.0 minutes (free) or 1.8 to 3.0 minutes (total) earlier for faster aspart vs IAsp (P < .05). Treatment ratios (faster aspart/IAsp) for 0 to 30 minutes IAsp exposure were 1.60 to 2.11 and 1.62 to 1.96, respectively (children, free: P = .062; otherwise P < .05). The ratio of free/total IAsp for overall exposure (AUC

conclusionsIn children and adolescents with T1D, faster aspart provides ultrafast pharmacokinetics irrespective of free or total IAsp assay. Elevated anti-IAsp antibodies are associated with higher total IAsp concentration, but do not impact faster aspart and IAsp glucose-lowering effect.

Indexed as

Insulin AspartAdolescentAdultAge FactorsBlood GlucoseChildCross-Over StudiesDiabetes Mellitus, Type 1Drug CompoundingFemaleHumansInsulin AntibodiesMaleMiddle AgedYoung AdultBlood GlucoseInsulin AntibodiesInsulin Aspartadolescentschildreninsulin antibodiespharmacodynamicspharmacokinetics

Identifiers

PMID32306477
PMCPMC7383777
OpenAlexW3017181326

What OpenQuestion holds

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LicenceCC BY-NC
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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.