Evidence map›Paper›PMID 27484286›Full record

Trial reportDiabetes, obesity & metabolism2017

Duration of action of two insulin glargine products, LY2963016 insulin glargine and Lantus insulin glargine, in subjects with type 1 diabetes mellitus.

Helle Linnebjerg, Eric Chen Quin Lam, Xin Zhang, Mary E Seger, David Coutant, Laiyi Chua, Christoph Kapitza, Tim Heise

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Review
  6. Review
  7. Article
  8. Observational
  9. Clinical Use of Degludec in Children and Adolescents with T1D: A Narrative Review with Fictionalized Case Reports.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2019
    Review
  10. Biosimilar and Follow-on Insulin: The Ins, Outs, and Interchangeability.The Journal of pharmacy technology : jPT : official publication of the Association of Pharmacy Technicians · 2019
    Review
  11. Lilly Insulin Glargine Versus LantusDiabetes therapy : research, treatment and education of diabetes and related disorders · 2019
    Article
  12. Similar Intrapatient Blood Glucose Variability with LY2963016 and LantusDiabetes therapy : research, treatment and education of diabetes and related disorders · 2018
    Article
  13. A Review of Basal-Bolus Therapy Using Insulin Glargine and Insulin Lispro in the Management of Diabetes Mellitus.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2018
    Review
  14. Introduction of biosimilar insulins in Europe.Diabetic medicine : a journal of the British Diabetic Association · 2017
    Review
  15. Review
  16. Review
  17. 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

8 authors.

Helle LinnebjergEli Lilly and Company, Indianapolis, Indiana.
Eric Chen Quin LamLilly-NUS Centre for Clinical Pharmacology, Singapore, Singapore.
Xin ZhangEli Lilly and Company, Indianapolis, Indiana.
Mary E SegerEli Lilly and Company, Indianapolis, Indiana.
David CoutantEli Lilly and Company, Indianapolis, Indiana.
Laiyi ChuaLilly-NUS Centre for Clinical Pharmacology, Singapore, Singapore.
Christoph KapitzaProfil, Neuss, Germany.
Tim HeiseProfil, Neuss, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsLY2963016 (LY IGlar) and Lantus (IGlar) are insulin glargine products manufactured by distinct processes, but with identical amino acid sequences. This study compared the duration of action of LY IGlar and IGlar in subjects with type 1 diabetes mellitus (T1DM). MATERIALS AND

methodsThis was a randomized, double-blind, single-dose, two-period, crossover study. Twenty subjects underwent 42-hour euglycaemic clamps after a single subcutaneous 0.3-U/kg dose of LY IGlar or IGlar. In this study, the duration of action was defined as the time required for blood glucose levels to rise consistently above a predefined cut-off of 8.3 mmol/L (150 mg/dL) from a state of euglycaemia. Blood samples were collected to measure blood glucose for pharmacodynamic (PD) evaluations.

resultsEnd of action was reached within 42 hours in 26 of 40 clamps (13 LY IGlar and 13 IGlar). The median duration of action for all subjects was 37.1 and 40.0 hours, and the mean duration of action (calculated using only patients who reached end of action) was 23.8 and 25.5 hours for LY IGlar and IGlar, respectively. The duration of action was demonstrated to be similar between the treatments using time-to-event analysis (log-rank test of equality p = .859). Following administration of LY IGlar and IGlar, the PD parameters of maximum glucose infusion rate (R

conclusionLY IGlar and IGlar had similar duration of action and comparable PD parameters in subjects with T1DM.

Indexed as

AdultBlood GlucoseCross-Over StudiesDiabetes Mellitus, Type 1Double-Blind MethodFemaleGlucose Clamp TechniqueHumansHypoglycemic AgentsInsulin GlargineMaleMiddle AgedTime FactorsBlood GlucoseHypoglycemic AgentsInsulin GlargineLY2963016 insulin glarginebasal insulinbiosimilar insulinclinical trialpharmacodynamicsphase I-II studytype 1 diabetes

Identifiers

PMID27484286
PMCPMC5215447

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Registered trials

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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.