Evidence map›Paper›PMID 30259644›Full record

Trial reportDiabetes, obesity & metabolism2018

Fast-acting insulin aspart versus insulin aspart in the setting of insulin degludec-treated type 1 diabetes: Efficacy and safety from a randomized double-blind trial.

John B Buse, Anders L Carlson, Mitsuhisa Komatsu, Ofri Mosenzon, Ludger Rose, Bo Liang, Kristine Buchholtz, Hiroshi Horio, Takashi Kadowaki

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

Trial report in Diabetes, obesity & metabolism, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 22 papers.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed
5.7field-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.

NCT02500706 phase3completednot on this map

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

TypeinterventionalSponsorNovo Nordisk A/SRan2016 to 2017Enrolled1,108ConditionsDiabetes, Diabetes Mellitus, Type 1ArmsFaster-acting insulin aspart, insulin aspart, insulin degludec
NCT06546657 completednot on this mapstarted 2021, after this paper: background citation

An Investigation Into Diurnal Variability in Glucose Levels in Paediatric Patients With Type 1 Diabetes (T1D) and Their Responses to Different Food Compositions

TypeobservationalSponsorUniversity of StirlingRan2021 to 2021Enrolled96ConditionsType 1 DiabetesArmsBreakfast
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 54 citations in OpenAlex.

  1. Trial
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  8. Observational
  9. Article
  10. Article
  11. Review
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  13. Article
  14. Glycaemic Control in People with Diabetes Starting Treatment with Fast-Acting Insulin Aspart: a US Database Study.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2021
    Article
  15. Diabetes Technology and Therapy in the Pediatric Age Group.Diabetes technology & therapeutics · 2021
    Article
  16. Article
  17. Review
  18. Insulin Therapy in Adults with Type 1 Diabetes Mellitus: a Narrative Review.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2020 · on this map
    Review
  19. Review
  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.

John B BuseDivision of Endocrinology, Department of Medicine, University of North Carolina School of Medicine, North Carolina.ORCID 0000-0002-9723-3876
Anders L CarlsonInternational Diabetes Center, Minneapolis, Minnesota.
Mitsuhisa KomatsuDivision of Diabetes, Endocrinology and Metabolism, Department of Internal Medicine, Shinshu University School of Medicine, Nagano, Japan.
Ofri MosenzonDiabetes Unit, Division of Internal Medicine, Hadassah Hebrew University Hospital, Jerusalem, Israel.
Ludger RoseInstitute of Diabetes Research, Münster, Germany.
Bo LiangNovo Nordisk A/S, Søborg, Denmark.
Kristine BuchholtzNovo Nordisk A/S, Søborg, Denmark.
Hiroshi HorioNovo Nordisk Pharma Ltd, Tokyo, Japan.
Takashi KadowakiDepartment of Diabetes and Metabolic Diseases, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
Novo Nordisk (Denmark) · DKGerman Center for Diabetes Research · DEHebrew University of Jerusalem · ILInternational Diabetes Federation · BEShinshu University · JPThe University of Tokyo · JPUniversity of North Carolina at Chapel Hill · US

Funding

Re-Entry Supplement: Investigation of Oral Microbial Enzymes for the Detection and Treatment of Periodontal DiseaseUL1TR002489 · NCATS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI BUSE, JOHN BERNARD, SHAHEEN, NICHOLAS J · 2018 to 2022
$48.6M
NCATS NIH HHS UL1 TR002489
6 · The paper itself

Abstract

aimTo evaluate the efficacy and safety of mealtime or post-meal fast-acting insulin aspart (faster aspart) vs mealtime insulin aspart (IAsp), both in combination with insulin degludec, in participants with type 1 diabetes (T1D).

methodsThis multicentre, treat-to-target trial (Clinical trial registry: NCT02500706, ClinicalTrials.gov) randomized participants to double-blind mealtime faster aspart (n = 342) or IAsp (n = 342) or open-label post-meal faster aspart (n = 341). The primary endpoint was change from baseline in HbA1c 26 weeks post randomization. All available information, regardless of treatment discontinuation, was used for evaluation of the effect.

resultsNon-inferiority for the change from baseline in HbA1c was confirmed for mealtime and post-meal faster aspart vs IAsp (estimated treatment difference [ETD]: 95%CI, -0.02% [-0.11; 0.07] and 0.10% [0.004; 0.19], respectively). Mealtime faster aspart was superior to IAsp for 1-hour PPG increment using a meal test (ETD, -0.90 mmol/L [-1.36; -0.45]; P < 0.001). Self-monitored 1-hour PPG increment favoured faster aspart at breakfast (ETD, -0.58 mmol/L [-0.99; -0.17]; P = 0.006) and across all meals (-0.48 mmol/L [-0.74; -0.21]; P < 0.001). Safety profiles and overall rate of severe or blood glucose-confirmed hypoglycaemia were similar between treatments, but significantly less hypoglycaemia was seen 3 to 4 hours after meals with mealtime faster aspart.

conclusionMealtime and post-meal faster aspart in conjunction with insulin degludec provided effective glycaemic control compared with IAsp, with no increased safety risk. Mealtime faster aspart provided PPG control superior to that of IAsp.

Indexed as

AdolescentAdultBlood GlucoseDiabetes Mellitus, Type 1Double-Blind MethodDrug CombinationsFemaleGlycated HemoglobinHumansHypoglycemiaHypoglycemic AgentsInsulin AspartInsulin, Long-ActingMaleMealsMiddle AgedBlood GlucoseDrug CombinationsGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsInsulin Aspartinsulin degludec, insulin aspart drug combinationInsulin, Long-Actingclinical trialhypoglycaemiainsulin therapytype 1 diabetes

Identifiers

PMID30259644
PMCPMC6231963
OpenAlexW2893716860

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.