Evidence map›Paper›PMID 30402720›Full record

Trial reportClinical pharmacokinetics2019

Clinical Pharmacology of Fast-Acting Insulin Aspart Versus Insulin Aspart Measured as Free or Total Insulin Aspart and the Relation to Anti-Insulin Aspart Antibody Levels in Subjects with Type 1 Diabetes Mellitus.

Hanne Haahr, Thomas R Pieber, Chantal Mathieu, Theis Gondolf, Masanari Shiramoto, Lars Erichsen, Tim Heise

5 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Clinical pharmacokinetics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 5 registered trials, which are not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.3field-weighted citation impact, top 18% 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.

NCT01618188 phase1completednot on this map

A Trial Investigating the Pharmacodynamic Properties of NN1218 in Subjects With Type 1 Diabetes

TypeinterventionalSponsorNovo Nordisk A/SRan2012 to 2012Enrolled52ConditionsDiabetes, Diabetes Mellitus, Type 1ArmsFaster-acting insulin aspart, insulin aspart
NCT01831765 phase3completednot on this map

Efficacy and Safety of FIAsp Compared to Insulin Aspart Both in Combination With Insulin Detemir in Adults With Type 1 Diabetes

TypeinterventionalSponsorNovo Nordisk A/SRan2013 to 2015Enrolled1,290ConditionsDiabetes, Diabetes Mellitus, Type 1ArmsFaster-acting insulin aspart, insulin detemir, insulin aspart
NCT01934712 phase1completednot on this map

A Trial Investigating the Pharmacokinetic Properties of FIAsp in Japanese Subjects With Type 1 Diabetes

TypeinterventionalSponsorNovo Nordisk A/SRan2013 to 2014Enrolled50ConditionsDiabetes, Diabetes Mellitus, Type 1ArmsFaster-acting insulin aspart, insulin aspart
NCT02003677 phase1completednot on this map

A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of FIAsp in Geriatric and Younger Adult Subjects With Type 1 Diabetes

TypeinterventionalSponsorNovo Nordisk A/SRan2013 to 2014Enrolled67ConditionsDiabetes, Diabetes Mellitus, Type 1ArmsFaster-acting insulin aspart, insulin aspart
NCT02568280 phase1completednot on this map

A Randomised Trial Investigating the Postprandial Glucose Metabolism After Treatment With Faster-acting Insulin Aspart in Subjects With Type 1 Diabetes

TypeinterventionalSponsorNovo Nordisk A/SRan2015 to 2016Enrolled42ConditionsDiabetes, Diabetes Mellitus, Type 1ArmsFaster-acting insulin aspart, insulin aspart
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 11 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. 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

7 authors at 5 institutions in 5 countries.

Hanne HaahrNovo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark. hhaa@novonordisk.com.
Thomas R PieberDepartment of Internal Medicine, Medical University of Graz, Auenbruggerplatz 15, 8036, Graz, Austria.
Chantal MathieuClinical and Experimental Endocrinology, University Hospital Leuven, KU Leuven, UZ Herestraat 49, Box 902, 3000, Leuven, Belgium.
Theis GondolfNovo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark.
Masanari ShiramotoSOUSEIKAI, Hakata Clinic, 6-18 Tenyamachi, Hakata-ku, Fukuoka, 812-0025, Japan.
Lars ErichsenNovo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark.
Tim HeiseProfil, Hellersbergstrasse 9, 41460, Neuss, Germany.
Novo Nordisk (Denmark) · DKKU Leuven · BEMedical University of Graz · ATProfil Institute for Metabolic Research · DESOUSEIKAI Global Clinical Research Center · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFast-acting insulin aspart (faster aspart) is an ultra-fast-acting formulation of insulin aspart (IAsp). This post hoc analysis investigated the pharmacokinetics of faster aspart versus IAsp, measured as free or total IAsp, and the relationship between anti-IAsp antibodies and the pharmacokinetics/pharmacodynamics of faster aspart and IAsp.

methodsFree and total IAsp concentrations and anti-IAsp antibodies were determined in adults with type 1 diabetes mellitus receiving subcutaneous faster aspart and/or IAsp in four single-dose clinical pharmacology trials (n = 175) and a 26-week phase IIIa trial (n = 1040). Pharmacodynamics were assessed by euglycaemic clamp or meal test, respectively.

resultsThe pharmacokinetic profile was left-shifted and early exposure was greater with faster aspart versus IAsp independent of free or total IAsp assay. The faster aspart-IAsp difference in the time to 50% of maximum IAsp concentration in the early part of the pharmacokinetic profile (t

conclusionsFaster aspart provides accelerated pharmacokinetics versus IAsp regardless if based on free or total IAsp assay. Higher anti-IAsp antibodies increase total IAsp concentrations but do not influence faster aspart nor IAsp pharmacodynamics. CLINICALTRIALS. GOV IDENTIFIERS: NCT01618188, NCT02003677, NCT01934712, NCT02568280, NCT01831765.

Indexed as

Diabetes Mellitus, Type 1AdultAgedAntibodiesBlood GlucoseCross-Over StudiesDouble-Blind MethodFemaleHumansHypoglycemic AgentsInsulin AspartMaleMiddle AgedYoung AdultAntibodiesBlood GlucoseHypoglycemic AgentsInsulin Aspart

Identifiers

PMID30402720
PMCPMC6451708
OpenAlexW2899746348

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.