Evidence map›Paper›PMID 32468447›Full record

Trial reportClinical pharmacokinetics2020

Pharmacokinetics and Glucodynamics of Ultra Rapid Lispro (URLi) versus Humalog

Helle Linnebjerg, Qianyi Zhang, Elizabeth LaBell, Mary Anne Dellva, David E Coutant, Ulrike Hövelmann, Leona Plum-Mörschel, Theresa Herbrand, Jennifer Leohr

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

Trial report in Clinical pharmacokinetics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03166124 (Pharmacokinetics and Glucodynamics of LY900014 Compared to Insulin Lispro Following Single Dose Administration in Elderly and Younger Adults With Type 1 Diabetes Mellitus), which is not on this map. Cited by 28 papers.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed
6.8field-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.

NCT03166124 phase1completednot on this map

Pharmacokinetics and Glucodynamics of LY900014 Compared to Insulin Lispro Following Single Dose Administration in Elderly and Younger Adults With Type 1 Diabetes Mellitus

TypeinterventionalSponsorEli Lilly and CompanyRan2017 to 2017Enrolled80ConditionsDiabetes Mellitus, Type 1ArmsLY900014, Insulin Lispro
3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 55 citations in OpenAlex.

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  7. Review
  8. Article
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  11. Prandial Insulins: A Person-Centered Choice.Current diabetes reports · 2024
    Review
  12. Article
  13. Article
  14. Review
  15. Article
  16. Article
  17. Efficacy and Safety of Ultra-Rapid Lispro in Younger and Older Patients with Type 2 Diabetes: Randomized Double-Blind PRONTO-T2D Study.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2022
    Article
  18. Article
  19. New Horizons: Next-Generation Insulin Analogues: Structural Principles and Clinical Goals.The Journal of clinical endocrinology and metabolism · 2022
    Review
  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

9 authors at 2 institutions in 2 countries.

Helle LinnebjergEli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA. linnebjerg_helle@lilly.com.
Qianyi ZhangEli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.
Elizabeth LaBellEli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.
Mary Anne DellvaEli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.
David E CoutantEli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.
Ulrike HövelmannProfil, Neuss, Germany.
Leona Plum-MörschelProfil, Mainz, Germany.
Theresa HerbrandProfil, Neuss, Germany.
Jennifer LeohrEli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.
Eli Lilly (United States) · USProfil Institute for Metabolic Research · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundUltra rapid lispro (URLi) is a novel insulin lispro formulation developed to more closely match physiological insulin secretion and improve postprandial glucose control. This study compared the pharmacokinetics, glucodynamics, safety, and tolerability of URLi and Humalog

methodsThis was a phase I, two-period, randomised, double-blind, crossover glucose clamp study in younger adult (aged 18-45 years; n = 41) and elderly (aged ≥65 years; n = 39) patients with T1DM. At each dosing visit, patients received either URLi or Humalog (15 units subcutaneously) followed by a 10 h automated euglycaemic clamp procedure. Serum insulin lispro and blood glucose were measured.

resultsInsulin lispro appeared in serum 6 min faster, and exposure was 7.2-fold greater over the first 15 min postdose with URLi versus Humalog in both age groups. Exposure beyond 3 h postdose was 39-41% lower, and exposure duration was reduced by 72-74 min with URLi versus Humalog in both age groups. Onset of insulin action was 11-12 min faster, and insulin action was 3-fold greater over the first 30 min postdose with URLi versus Humalog in both age groups. Insulin action beyond 4 h postdose was 44-54% lower, and duration of action was reduced by 34-44 min with URLi versus Humalog in both age groups. Overall exposure and total insulin action remained similar for both treatments. URLi and Humalog were well tolerated.

conclusionIn patients with T1DM, URLi showed ultra-rapid pharmacokinetics and glucodynamics, with the differences between URLi and Humalog in elderly patients mirroring those in younger adults. ClinicalTrials.gov identifier: NCT03166124.

Indexed as

Diabetes Mellitus, Type 1AdultAgedBlood GlucoseCross-Over StudiesFemaleGlucose Clamp TechniqueHumansHypoglycemic AgentsInsulin LisproMaleMiddle AgedYoung AdultBlood GlucoseHypoglycemic AgentsInsulin Lispro

Identifiers

PMID32468447
PMCPMC7716921
OpenAlexW3031048430

What OpenQuestion holds

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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.