Evidence map›Paper›PMID 29053231›Full record

Trial reportDiabetes, obesity & metabolism2018

Effects of common cold and concomitant administration of nasal decongestant on the pharmacokinetics and pharmacodynamics of nasal glucagon in otherwise healthy participants: A randomized clinical trial.

Cristina B Guzman, Helene Dulude, Claude Piché, Marianne Rufiange, Aziz A Sadoune, Emmanouil Rampakakis, Dolores Carballo, Myriam Triest, Michelle Xiaotian Zhang, Shuyu Zhang and 2 more

Registry-linked trialOpen access · hybridAbstract readRandomized 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 trial NCT05206149 (Stimulation Test With Intranasal Glucagon for Corticotroph, Somatotroph and Antidiuretic Axes), which is not on this map. Cited by 14 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 2 pooled it
1.5field-weighted citation impact, top 21% 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.

NCT05206149 phase4completednot on this mapstarted 2021, after this paper: background citation

Stimulation Test With Intranasal Glucagon for Corticotroph, Somatotroph and Antidiuretic Axes

TypeinterventionalSponsorA.O.U. Città della Salute e della ScienzaRan2021 to 2021Enrolled10ConditionsHypopituitarismArmsIntranasal glugagon, Intranasal placebo
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 2 syntheses or guidelines pooled it, 28 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. Pooled it
  3. Trial
  4. Article
  5. Nasal Glucagon.Hospital pharmacy · 2022
    Review
  6. Review
  7. Review
  8. Review
  9. Review
  10. Glucagon Therapy: A Comparison of Current and Novel Treatments.Diabetes spectrum : a publication of the American Diabetes Association · 2020
    Article
  11. Review
  12. Therapeutic Use of Intranasal Glucagon: Resolution of Hypoglycemia.International journal of molecular sciences · 2019
    Review
  13. Nasal Glucagon: A Promising New Way to Treat Severe Hypoglycemia.Clinical diabetes : a publication of the American Diabetes Association · 2019
    Article
  14. 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

12 authors at 3 institutions in 2 countries.

Cristina B GuzmanEli Lilly and Company, Indianapolis, Indiana.
Helene DuludeLocemia Solutions, Montréal, Québec, Canada.
Claude PichéLocemia Solutions, Montréal, Québec, Canada.
Marianne RufiangeAlgorithme Pharma Inc., Montréal, Québec, Canada.
Aziz A SadouneAlgorithme Pharma Inc., Montréal, Québec, Canada.
Emmanouil RampakakisJSS Medical Research, Montréal, Québec, Canada.
Dolores CarballoLocemia Solutions, Montréal, Québec, Canada.
Myriam TriestLocemia Solutions, Montréal, Québec, Canada.
Michelle Xiaotian ZhangEli Lilly Canada Inc., Toronto, Ontario, Canada.
Shuyu ZhangEli Lilly and Company, Indianapolis, Indiana.
Maryam TafreshiJSS Medical Research, Montréal, Québec, Canada.
Eric SicardAlgorithme Pharma Inc., Montréal, Québec, Canada.
Eli Lilly (United States) · USGDI Integrated Facility Services (Canada) · CAEli Lilly (Canada) · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsNasal glucagon (NG) is a nasally-administered glucagon powder, absorbed through the nasal mucosa, designed for treatment of severe hypoglycaemia. This study evaluated the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of NG in otherwise healthy participants with common colds and after recovery from cold symptoms, with and without concomitant nasal decongestant. MATERIALS AND

methodsThis was a single-centre, open-label study. Cohort 1 participants (N = 18) received 2 doses of NG: one while experiencing nasal congestion and another after recovery from cold symptoms. Cohort 2 participants (N = 18), who also had colds with nasal congestion, received a single dose of NG 2 hours after treatment with the decongestant oxymetazoline. Total symptoms score and other safety measures were assessed before and after NG administration.

resultsNG was well tolerated, without serious adverse events. Common adverse events (transient lacrimation, nasal discomfort, rhinorrhea and nausea) were more frequent in both Cohorts 1 and 2 during nasal congestion. Glucagon levels peaked 18 minutes post-dose and glucose levels peaked 30 to 42 minutes post-dose in all groups. Nasal congestion, with or without concomitant nasal decongestant, did not significantly affect PK of NG. Although glucose AUECs

conclusionsThere were no clinically relevant differences in safety or PK/PD of NG associated with nasal congestion or concomitant administration of nasal decongestant, suggesting that NG can be used to treat severe hypoglycaemia in individuals experiencing nasal congestion.

Indexed as

Administration, IntranasalAdultBlood GlucoseCommon ColdFemaleGastrointestinal AgentsGlucagonHealthy VolunteersHumansHypoglycemiaMaleNasal DecongestantsNasal ObstructionPowdersBlood GlucoseGastrointestinal AgentsGlucagonNasal DecongestantsPowdersglucagonhypoglycaemia

Identifiers

PMID29053231
PMCPMC5836949
OpenAlexW2765113122

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.