Evidence map›Paper›PMID 28556616›Full record

Trial reportJournal of diabetes investigation2018

Fast-acting insulin aspart in Japanese patients with type 1 diabetes: Faster onset, higher early exposure and greater early glucose-lowering effect relative to insulin aspart.

Masanari Shiramoto, Tomoyuki Nishida, Ann Kathrine Hansen, Hanne Haahr

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Journal of diabetes investigation, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01934712 (A Trial Investigating the Pharmacokinetic Properties of FIAsp in Japanese Subjects With Type 1 Diabetes), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
2.5field-weighted citation impact, top 10% 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.

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
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 20 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. Article
  5. Review
  6. Review
  7. Fast-Acting Insulin Aspart: The Rationale for a New Mealtime Insulin.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2019
    Review
  8. 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

4 authors at 2 institutions in 2 countries.

Masanari ShiramotoSOUSEIKAI, Hakata Clinic, Fukuoka, Japan.ORCID http://orcid.org/0000-0002-5109-7936
Tomoyuki NishidaNovo Nordisk Pharma Ltd., Tokyo, Japan.
Ann Kathrine HansenNovo Nordisk A/S, Søborg, Denmark.
Hanne HaahrNovo Nordisk A/S, Søborg, Denmark.
Novo Nordisk (Denmark) · DKSOUSEIKAI Global Clinical Research Center · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionFast-acting insulin aspart (faster aspart) is insulin aspart (IAsp) in a new formulation with two added excipients (niacinamide and L-arginine) in order to obtain accelerated absorption after subcutaneous dosing. The present study compared the pharmacokinetic/pharmacodynamic characteristics of faster aspart vs IAsp in Japanese patients with type 1 diabetes. MATERIALS AND

methodsIn a randomized, double-blind, cross-over design, 43 participants were given faster aspart and IAsp (0.2 U/kg single dose) at two separate dosing visits. Frequent pharmacokinetic blood sampling was carried out, and pharmacodynamics were assessed using an automated euglycemic clamp lasting for a maximum of 12 h after dosing (target 5.5 mmol/L).

resultsFaster aspart showed onset of appearance approximately twice-as-fast vs IAsp (least squares means: 3.0 vs 7.1 min; estimated treatment difference -4.1 min, 95% confidence interval [CI]: -5.0, -3.2; P < 0.001) and onset of action occurring approximately 5 min earlier (20.2 vs 25.5 min; estimated treatment difference -5.3 min, 95% CI: -8.4, -2.2; P = 0.001). Within the first 30 min post-dose, both exposure (area under the curve [AUC]

conclusionsFaster aspart showed faster onset, higher early exposure and a greater early glucose-lowering effect relative to IAsp in Japanese patients with type 1 diabetes, in accordance with previous findings in Caucasian type 1 diabetes patients.

Indexed as

AdultAsian PeopleCross-Over StudiesDiabetes Mellitus, Type 1Double-Blind MethodFemaleHumansHypoglycemic AgentsInsulin AspartJapanMaleMiddle AgedTreatment OutcomeYoung AdultHypoglycemic AgentsInsulin AspartJapanesePharmacodynamicsPharmacokinetics

Identifiers

PMID28556616
PMCPMC5835461
OpenAlexW2619526355

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.