Evidence map›Paper›PMID 30537180›Full record

Trial reportDiabetes, obesity & metabolism2019

A randomized, multicentre trial evaluating the efficacy and safety of fast-acting insulin aspart in continuous subcutaneous insulin infusion in adults with type 1 diabetes (onset 5).

David C Klonoff, Mark L Evans, Wendy Lane, Hans-Peter Kempe, Eric Renard, J Hans DeVries, Tina Graungaard, Agon Hyseni, Theis Gondolf, Tadej Battelino

2 registry-linked trialsOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2019. 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 32 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 1 pooled it
6.2field-weighted citation impact, top 2% 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.

NCT02825251 phase3completednot on this map

Efficacy and Safety of Continuous Subcutaneous Insulin Infusion of Faster-acting Insulin Aspart Compared to NovoRapid® in Adults With Type 1 Diabetes

TypeinterventionalSponsorNovo Nordisk A/SRan2016 to 2017Enrolled472ConditionsDiabetes, Diabetes Mellitus, Type 1ArmsFaster-acting insulin aspart, insulin aspart
NCT04414579 phase4unknown statusnot on this map

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

32 citing papers in PubMed, 1 synthesis or guideline pooled it, 76 citations in OpenAlex.

  1. 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
  2. Trial
  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. Article
  11. Review
  12. Article
  13. Article
  14. Review
  15. The Nuances Surrounding Insulin Prescribing.Clinical diabetes : a publication of the American Diabetes Association · 2023
    Article
  16. Review
  17. Article
  18. Article
  19. Article
  20. 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
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

10 authors at 8 institutions in 7 countries.

David C KlonoffDiabetes Research Institute, Mills-Peninsula Medical Center, San Mateo, California.ORCID 0000-0002-0624-698X
Mark L EvansWellcome Trust/MRC Institute of Metabolic Science and Department of Medicine, University of Cambridge, Cambridge, UK.
Wendy LaneMountain Diabetes and Endocrine Center, Asheville, North Carolina.
Hans-Peter KempeCentre for Diabetes and Nutrition Ludwigshafen, Ludwigshafen, Germany.
Eric RenardDepartment of Endocrinology, Diabetes, and Nutrition and Clinical Investigation Centre, Montpellier University Hospital, Institute of Functional Genomics, CNRS, INSERM, University of Montpellier, Montpellier, France.ORCID 0000-0002-3407-7263
J Hans DeVriesAcademic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.ORCID 0000-0001-9196-9906
Tina GraungaardNovo Nordisk A/S, Aalborg, Denmark.
Agon HyseniNovo Nordisk A/S, Søborg, Denmark.
Theis GondolfNovo Nordisk A/S, Søborg, Denmark.
Tadej BattelinoDepartment of Endocrinology, Diabetes and Metabolic Diseases, University Children's Hospital Ljubljana, and Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.ORCID 0000-0002-0273-4732
Novo Nordisk (Denmark) · DKCentre National de la Recherche Scientifique · FRLudwigshafen University of Business and Society · DEMills Peninsula Health Services · USMountain Diabetes and Endocrine Center · USUniversity Medical Center · USUniversity of Ljubljana · SIWellcome/MRC Institute of Metabolic Science · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimTo evaluate the efficacy and safety of fast-acting insulin aspart (faster aspart) vs insulin aspart (IAsp) used in continuous subcutaneous insulin infusion (CSII) in participants with type 1 diabetes (T1D). MATERIALS AND

methodsThis was a double-blind, treat-to-target, randomized, 16-week trial investigating CSII treatment with faster aspart (n = 236) or IAsp (n = 236). All available information, regardless of treatment discontinuation, was used for the evaluation of effect.

resultsFaster aspart was non-inferior to IAsp regarding the change from baseline in glycated haemoglobin (HbA1c; primary endpoint). The mean HbA1c changed from 58.4 mmol/mol (7.5%) at baseline to 57.8 mmol/mol (7.4%) with faster aspart and to 56.8 mmol/mol (7.4%) with IAsp after 16 weeks' treatment, with an estimated treatment difference (ETD) of 1.0 mmol/mol (95% confidence interval [CI] 0.14; 1.87) or 0.09% (95% CI 0.01; 0.17; P < 0.001) for non-inferiority (0.4% margin; P < 0.02 for statistical significance in favour of IAsp). Faster aspart was superior to IAsp in change from baseline in 1-hour postprandial glucose (PPG) increment after a meal test (ETD -0.91 mmol/L [95% CI -1.43; -0.39] or -16.4 mg/dL [95% CI -25.7; -7.0]; P = 0.001), with statistically significant reductions also at 30 minutes and 2 hours. The improvement in PPG was reflected in the change from baseline in 1-hour interstitial glucose increment after all meals (ETD -0.21 mmol/L [95% CI -0.31; -0.11] or -3.77 mg/dL [95% CI -5.53; -2.01]). There was no statistically significant difference in the overall rate of severe or blood glucose-confirmed hypoglycaemia (estimated rate ratio 1.00 [95% CI 0.85; 1.16]). A numerical imbalance in severe hypoglycaemic episodes between faster aspart and IAsp was seen in the treatment (21 vs 7) and 4-week run-in periods (4 vs 0).

conclusionsFaster aspart provides an effective and safe option for CSII treatment in T1D.

Indexed as

AdultDiabetes Mellitus, Type 1Dosage FormsDouble-Blind MethodExcipientsFemaleGlycated HemoglobinHumansHypoglycemiaHypoglycemic AgentsInfusions, SubcutaneousInsulin AspartInsulin Infusion SystemsMaleMiddle AgedDosage FormsExcipientsGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsInsulin Aspartclinical trialCSIIinsulin therapytype 1 diabetes

Identifiers

PMID30537180
PMCPMC6590130
OpenAlexW2905425319

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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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.