Evidence map›Paper›PMID 32514794›Full record

ArticleDiabetes therapy : research, treatment and education of diabetes and related disorders2020

Glucagon Administration by Nasal and Intramuscular Routes in Adults With Type 1 Diabetes During Insulin-Induced Hypoglycaemia: A Randomised, Open-Label, Crossover Study.

Jeffrey G Suico, Ulrike Hövelmann, Shuyu Zhang, Tong Shen, Brandon Bergman, Jennifer Sherr, Eric Zijlstra, Brian M Frier, Leona Plum-Mörschel

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Diabetes therapy : research, treatment and education of diabetes and related disorders, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03339453 (Comparison of Glucagon Administered by Either the Nasal), which is not on this map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
2.8field-weighted citation impact, top 8% 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.

NCT03339453 phase1completednot on this map

Comparison of Glucagon Administered by Either the Nasal (LY900018) or Intra-muscular (GlucaGen®) Routes in Adult Patients With Type 1 Diabetes Mellitus During Controlled Insulin-Induced Hypoglycemia

TypeinterventionalSponsorEli Lilly and CompanyRan2017 to 2018Enrolled70ConditionsHypoglycemia, Diabetes Mellitus, Type 1ArmsNasal Glucagon, Intramuscular Glucagon
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 31 citations in OpenAlex.

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  8. Systematic Literature Review and Indirect Treatment Comparison of Three Ready-to-Use Glucagon Treatments for Severe Hypoglycemia.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2023
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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 4 institutions in 3 countries.

Jeffrey G SuicoEli Lilly and Company, Indianapolis, IN, USA. suico_jeffrey_gideon@lilly.com.ORCID https://orcid.org/0000-0002-1353-9043
Ulrike HövelmannProfil, Neuss, Germany.
Shuyu ZhangEli Lilly and Company, Indianapolis, IN, USA.
Tong ShenEli Lilly and Company, Indianapolis, IN, USA.
Brandon BergmanEli Lilly and Company, Indianapolis, IN, USA.
Jennifer SherrEndocrinology, Department of Pediatrics (Endocrinology), Yale School of Medicine, New Haven, CT, USA.
Eric ZijlstraProfil, Neuss, Germany.
Brian M FrierThe Queen's Medical Research Institute, University of Edinburgh, Edinburgh, UK.
Leona Plum-MörschelProfil, Mainz, Germany.
Eli Lilly (United States) · USProfil Institute for Metabolic Research · DEThe Queen's Medical Research Institute · GBYale University · US

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
Yale Diabetes Research CenterP30DK045735 · NIDDK · YALE UNIVERSITY · PI Richard A Flavell · 1993 to 2026
$44.0M
NCATS NIH HHS UL1 TR001863NIDDK NIH HHS P30 DK045735
6 · The paper itself

Abstract

introductionMany commercially available glucagon products for treatment of severe hypoglycaemia require cumbersome reconstitution and potentially intimidating injection during an emergency. Nasal glucagon (NG) is a novel drug-device combination product consisting of a single-use dosing device that delivers glucagon dry powder through nasal administration. The present study assessed whether 3 mg NG was non-inferior to 1 mg intramuscular glucagon (IMG) in adults with type 1 diabetes.

methodsThis randomised, open-label, two-period, crossover trial was conducted at two clinical sites. Hypoglycaemia (plasma glucose [PG] target of < 3.3 mmol/l (60 mg/dl) was induced by an intravenous insulin infusion. Glucagon preparations were given by study staff. Treatment success was defined as an increase in PG to ≥ 3.9 mmol/l (70 mg/dl) or an increase of ≥ 1.1 mmol/l (20 mg/dl) from the PG nadir within 30 min of receiving glucagon.

resultsOf the 66 participants included in the primary efficacy analysis who received both NG and IMG, 100% achieved treatment success, thus demonstrating non-inferiority of NG to IMG. All participants achieved treatment success within 25 min with the mean time to treatment success of 11.4 min (NG) and 9.9 min (IMG). No serious adverse events occurred. Forty-eight treatment-emergent adverse events (TEAEs) occurred after NG and 51 after IMG. Most TEAEs were mild and transient.

conclusionNasal glucagon was as efficacious and well tolerated as IMG for the treatment of insulin-induced hypoglycaemia in adults and will be as useful as IMG as a rescue treatment for severe hypoglycaemia.

trial registrationNCT03339453, ClinicalTrials.gov.

Indexed as

Insulin-induced hypoglycaemiaIntramuscular glucagonNasal glucagonType 1 diabetes

Identifiers

PMID32514794
PMCPMC7324463
OpenAlexW3033451567

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.