Evidence map›Paper›PMID 29316130›Full record

Trial reportDiabetes, obesity & metabolism2018

Efficacy and safety of fast-acting insulin aspart in comparison with insulin aspart in type 1 diabetes (onset 1): A 52-week, randomized, treat-to-target, phase III trial.

Chantal Mathieu, Bruce W Bode, Edward Franek, Athena Philis-Tsimikas, Ludger Rose, Tina Graungaard, Anne Birk Østerskov, David Russell-Jones

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
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 trial NCT01831765 (Efficacy and Safety of FIAsp Compared to Insulin Aspart Both in Combination With Insulin Detemir in Adults With Type 1 Diabetes), which is not on this map. Cited by 45 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
45citing papers in PubMed, 2 pooled it
9.1field-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.

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
3 · Its place in the literature

Who cites it

45 citing papers in PubMed, 2 syntheses or guidelines pooled it, 93 citations in OpenAlex.

  1. Guideline
  2. American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update.Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists · 2022
    Guideline
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Fast-Acting Insulin Aspart Use with the MiniMedDiabetes technology & therapeutics · 2021
    Trial
  9. Trial
  10. Trial
  11. Trial
  12. Trial
  13. Article
  14. Article
  15. Article
  16. Article
  17. Observational
  18. Article
  19. Gaps Remain for Achieving HbA1c Targets for People with Type 1 or Type 2 Diabetes Using Insulin: Results from NHANES 2009-2020.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2023
    Article
  20. 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

8 authors at 7 institutions in 6 countries.

Chantal MathieuClinical and Experimental Endocrinology, University Hospital Leuven, Leuven, Belgium.ORCID 0000-0002-4055-5233
Bruce W BodeAtlanta Diabetes Associates, Atlanta, Georgia.
Edward FranekMossakowski Clinical Research Centre, Polish Academy of Sciences, Warsaw, Poland.
Athena Philis-TsimikasScripps Whittier Diabetes Institute, Scripps Health, San Diego, California.
Ludger RoseInstitute of Diabetes Research, Münster, Germany.
Tina GraungaardBiostatistics Aalborg 2, Novo Nordisk A/S, Aalborg, Denmark.
Anne Birk ØsterskovMedical & Science, Insulin & Digital Health, Novo Nordisk A/S, Søborg, Denmark.
David Russell-JonesDiabetes and Endocrinology, Royal Surrey County Hospital and University of Surrey, Guildford, UK.
Novo Nordisk (Denmark) · DKAtlanta Diabetes Associates · USGerman Center for Diabetes Research · DEKU Leuven · BEMossakowski Medical Research Institute, Polish Academy of Sciences · PLRoyal Surrey County Hospital · GBScripps Health · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsTo compare the safety and efficacy of fast-acting insulin aspart (faster aspart) with conventional insulin aspart (IAsp) in adults with type 1 diabetes (T1D). MATERIALS AND

methodsonset 1 was a randomized, multicentre, treat-to-target, phase III, 52-week (initial 26 weeks + additional 26 weeks) trial conducted at 165 sites across 9 countries. Adults with T1D were randomly allocated to double-blind mealtime faster aspart or IAsp, each with once- or twice-daily insulin detemir. The primary endpoint, change in glycated haemoglobin (HbA1c) from baseline after the initial 26 weeks, has been reported previously. In the present paper, we report data from the full 52-week study period.

resultsBetween August 2013 and June 2015, 381 participants were assigned to double-blind faster aspart and 380 participants to IAsp. After 52 weeks, estimated mean changes from baseline in HbA1c levels were -0.08% (faster aspart) and +0.01% (IAsp); estimated treatment difference significantly favoured faster aspart (-0.10% [95% confidence interval {CI} -0.19;-0.00]; P = .0424). Changes from baseline in 1-hour postprandial plasma glucose (PPG) increment (meal test; faster aspart -1.05 mmol/L; IAsp -0.14 mmol/L) also significantly favoured faster aspart (estimated treatment difference -0.91 mmol/L [95% CI -1.40;-0.43]; -16.48 mg/dL [95% CI -25.17;-7.80]; P = .0002). There was no difference in overall severe or blood glucose-confirmed hypoglycaemic episodes or treatment-emergent adverse events between treatments.

conclusionsAt 52 weeks, overall glycaemic control had significantly improved with faster aspart vs IAsp, consistent with the 26-week study findings. Achieving an insulin profile closer to physiological insulin secretion with faster aspart translates into lower PPG and HbA1c levels compared with those achieved with IAsp in people with T1D.

Indexed as

Drug CompoundingAdultBlood GlucoseBlood Glucose Self-MonitoringDiabetes Mellitus, Type 1Dose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleDrug MonitoringDrug Therapy, CombinationFemaleFollow-Up StudiesGlycated HemoglobinHumansHyperglycemiaHypoglycemiaBlood GlucoseGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsInsulin AspartInsulin Detemirinsulin therapytype 1 diabetes

Identifiers

PMID29316130
PMCPMC5947306
OpenAlexW2784184843

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.