Evidence map›Paper›PMID 28205039›Full record

ArticleClinical pharmacokinetics2017

A Pooled Analysis of Clinical Pharmacology Trials Investigating the Pharmacokinetic and Pharmacodynamic Characteristics of Fast-Acting Insulin Aspart in Adults with Type 1 Diabetes.

Tim Heise, Thomas R Pieber, Thomas Danne, Lars Erichsen, Hanne Haahr

7 registry-linked trialsOpen access · hybridAbstract read
In one paragraph

Article in Clinical pharmacokinetics, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 7 registered trials, which are not on this map. Cited by 75 papers.

0numbers the graph read from it
0cells of the map it votes in
75citing papers in PubMed
15.8field-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.

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
NCT01924637 phase1completednot on this map

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

TypeinterventionalSponsorNovo Nordisk A/SRan2013 to 2013Enrolled36ConditionsDiabetes, 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
NCT02033239 phase1completednot on this map

A Trial Investigating the Pharmacodynamic Response of FIAsp in Subjects With Type 1 Diabetes

TypeinterventionalSponsorNovo Nordisk A/SRan2014 to 2014Enrolled46ConditionsDiabetes, Diabetes Mellitus, Type 1ArmsFaster-acting insulin aspart, insulin aspart
NCT02035371 phase1completednot on this map

A Trial Investigating the Pharmacokinetic Properties of FIAsp in Children, Adolescents and Adults With Type 1 Diabetes

TypeinterventionalSponsorNovo Nordisk A/SRan2014 to 2014Enrolled41ConditionsDiabetes, Diabetes Mellitus, Type 1ArmsFaster-acting insulin aspart, insulin aspart
NCT02131246 phase1completednot on this map

A Randomised Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of Faster-acting Insulin Aspart in Subjects With Type 1 Diabetes

TypeinterventionalSponsorNovo Nordisk A/SRan2014 to 2014Enrolled33ConditionsDiabetes, Diabetes Mellitus, Type 1ArmsFaster-acting insulin aspart, insulin aspart
NCT04414579 phase4unknown statusnot on this mapstarted 2019, after this paper: background citation

The Efficacy and Safety of Faster Insulin Aspart (Fiasp®) Compared to Conventional Insulin Aspart (NovoLog®) as Correction Bolus in Patients With Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion (CSII) and Continuous Glucose Monitoring (CGM): a Cross-over Controlled Trial

TypeinterventionalSponsorMountain Diabetes and Endocrine CenterRan2019 to 2021Enrolled45ConditionsType 1 Diabetes MellitusArmsFaster Insulin Aspart (Fiasp®)
3 · Its place in the literature

Who cites it

75 citing papers in PubMed, 178 citations in OpenAlex.

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15 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

5 authors at 4 institutions in 3 countries.

Tim HeiseProfil Institut für Stoffwechselforschung GmbH, Hellersbergstrasse 9, 41460, Neuss, Germany. tim.heise@profil.com.
Thomas R PieberMedical University of Graz, Auenbruggerplatz 15, 8036, Graz, Austria.
Thomas DanneChildren's and Youth Hospital AUF DER BULT, Janusz-Korczak-Allee 12, 30173, Hannover, Germany.
Lars ErichsenNovo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark.
Hanne HaahrNovo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark.
Novo Nordisk (Denmark) · DKKinderkrankenhaus auf der Bult · DEMedical University of Graz · ATProfil Institute for Metabolic Research · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFast-acting insulin aspart (faster aspart) is insulin aspart (IAsp) in a new formulation aiming to mimic the fast endogenous prandial insulin release more closely than currently available insulin products. In a post hoc analysis of pooled data from six clinical pharmacology trials, the pharmacological characteristics of faster aspart and IAsp were compared.

methodsThe analysis included 218 adult subjects with type 1 diabetes from six randomised, double-blind, crossover trials in the faster aspart clinical development programme. Subjects received subcutaneous dosing (0.2 U/kg) of faster aspart and IAsp. In three trials, a 12-h euglycaemic clamp was performed (target 5.5 mmol/L; 100 mg/dL) to assess pharmacodynamics.

resultsThe pharmacokinetic and pharmacodynamic profiles were left-shifted for faster aspart versus IAsp. Onset of appearance occurred 4.9 min earlier (95% confidence interval [CI] faster aspart-IAsp: [-5.3 to -4.4], p < 0.001), early exposure (AUC

conclusionsFaster aspart has the potential to better mimic the physiologic prandial insulin secretion and thereby to improve postprandial glucose control compared with IAsp. ClinicalTrials.gov identifiers: NCT02035371, NCT01924637, NCT02131246, NCT02033239, NCT02003677, NCT01618188.

Indexed as

AdultCross-Over StudiesDiabetes Mellitus, Type 1Double-Blind MethodFemaleHumansHypoglycemic AgentsInjections, SubcutaneousInsulin AspartMaleRandomized Controlled Trials as TopicHypoglycemic AgentsInsulin Aspart

Identifiers

PMID28205039
PMCPMC5385193
OpenAlexW2587826249

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

and 1 more above

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.