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Study · Randomized controlled trial · 2016

7 results

Glucagon Nasal Powder: A Promising Alternative to Intramuscular Glucagon in Youth With Type 1 Diabetes.

Sherr JL, Ruedy KJ, Foster NC, Piché CA, Dulude H, Rickels MR, Tamborlane WV, Bethin KE, DiMeglio LA, Fox LA, Wadwa RP, Schatz DA and 5 more

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Nathan BM, Marcovina SM, Rampakakis E, Meng L, Beck RW

Diabetes care16 Feb 2016Cited by 85 (Europe PMC)

PMID26884472 (opens in a new tab)PMCIDPMC4806770 (opens in a new tab)DOI10.2337/dc15-1606 (opens in a new tab)PepBankPUB-26884472
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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study7

7 results from studies that gave the peptide. 7 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In the youngest cohorts, efficacy was similar with 2- and 3-mg intranasal glucagon doses.

    In plain wordsIn the youngest children, nasal glucagon had similar efficacy at both doses.

    Peptide
    Glucagon
    Outcome
    No significant changeEfficacy by intranasal dose
    Study

    n: not reported in source

    Comparator
    3 mg intranasal glucagon
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    2 mg · intranasalAs given in this study (human).

    Source sentences

    Summary
    the efficacy and safety of the 2- and 3-mg intranasal doses were similar in the youngest cohorts.
    3 context sentences
    Summary · context
    A total of 48 youth with type 1 diabetes completed the study at seven clinical centers.
    Summary · context
    Participants in the two youngest cohorts (4 to <8 and 8 to <12 years old) were randomly assigned to receive either 2 or 3 mg intranasal glucagon in two separate sessions or to receive a single, weight-based dose of intramuscular glucagon.
    Summary · context
    Participants aged 12 to <17 years received 1 mg intramuscular glucagon in one session and 3 mg intranasal glucagon in the other session.
  2. 02HumanRandomized controlled trialSafety outcome

    In the youngest cohorts, safety was similar with 2- and 3-mg intranasal glucagon doses.

    In plain wordsIn the youngest children, nasal glucagon had similar safety at both doses.

    Peptide
    Glucagon
    Outcome
    No significant changeSafety by intranasal dose
    Study

    n: not reported in source

    Comparator
    3 mg intranasal glucagon
    Outcome group
    Adverse events · Whole body
    Studied dose
    2 mg · intranasalAs given in this study (human).

    Source sentences

    Summary
    the efficacy and safety of the 2- and 3-mg intranasal doses were similar in the youngest cohorts.
    3 context sentences
    Summary · context
    A total of 48 youth with type 1 diabetes completed the study at seven clinical centers.
    Summary · context
    Participants in the two youngest cohorts (4 to <8 and 8 to <12 years old) were randomly assigned to receive either 2 or 3 mg intranasal glucagon in two separate sessions or to receive a single, weight-based dose of intramuscular glucagon.
    Summary · context
    Participants aged 12 to <17 years received 1 mg intramuscular glucagon in one session and 3 mg intranasal glucagon in the other session.
  3. 03HumanNon-randomized trialEfficacy outcome

    In youth with type 1 diabetes, all 24 intramuscular glucagon doses raised glucose ≥25 mg/dL from nadir within 20 min.

    In plain wordsIn youth with type 1 diabetes, every intramuscular glucagon dose raised glucose from its lowest level.

    Peptide
    Glucagon
    Outcome
    IncreaseIntramuscular glucose response
    Study

    n: not reported in source

    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    weight-based dose in the two youngest cohorts; 1 mg in ages 12 to <17 years · intramuscularAs given in this study (human).

    Measurements

    Intramuscular doses with ≥25 mg/dL glucose rise within 20 min
    24 doses
    all 24 intramuscular doses, from nadir within 20 min of dosing

    Source sentences

    Summary
    All 24 intramuscular and 58 of the 59 intranasal doses produced a ≥25 mg/dL rise in glucose from nadir within 20 min of dosing.
    3 context sentences
    Summary · context
    A total of 48 youth with type 1 diabetes completed the study at seven clinical centers.
    Summary · context
    Participants in the two youngest cohorts (4 to <8 and 8 to <12 years old) were randomly assigned to receive either 2 or 3 mg intranasal glucagon in two separate sessions or to receive a single, weight-based dose of intramuscular glucagon.
    Summary · context
    Participants aged 12 to <17 years received 1 mg intramuscular glucagon in one session and 3 mg intranasal glucagon in the other session.
  4. 04HumanNon-randomized trialEfficacy outcome

    In youth with type 1 diabetes, 58 of 59 intranasal glucagon doses raised glucose ≥25 mg/dL from nadir within 20 min.

    In plain wordsIn youth with type 1 diabetes, most intranasal glucagon doses raised glucose from its lowest level.

    Peptide
    Glucagon
    Outcome
    IncreaseIntranasal glucose response
    Study

    n: not reported in source

    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    2 or 3 mg · intranasalAs given in this study (human).

    Measurements

    Intranasal doses with ≥25 mg/dL glucose rise within 20 min
    58 doses (of 59)
    intranasal doses, from nadir within 20 min of dosing

    Source sentences

    Summary
    All 24 intramuscular and 58 of the 59 intranasal doses produced a ≥25 mg/dL rise in glucose from nadir within 20 min of dosing.
    3 context sentences
    Summary · context
    A total of 48 youth with type 1 diabetes completed the study at seven clinical centers.
    Summary · context
    Participants in the two youngest cohorts (4 to <8 and 8 to <12 years old) were randomly assigned to receive either 2 or 3 mg intranasal glucagon in two separate sessions or to receive a single, weight-based dose of intramuscular glucagon.
    Summary · context
    Participants aged 12 to <17 years received 1 mg intramuscular glucagon in one session and 3 mg intranasal glucagon in the other session.
  5. 05HumanNon-randomized trialActivity measurement

    In youth with type 1 diabetes, time to peak plasma glucose was similar with intranasal and intramuscular glucagon.

    In plain wordsIn youth with type 1 diabetes, glucose peaked at similar times with nasal and injected glucagon.

    Peptide
    Glucagon
    Outcome
    No significant changeTime to peak plasma glucose
    Study

    n: not reported in source

    Comparator
    intramuscular glucagon
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    2 or 3 mg · intranasalAs given in this study (human).

    Source sentences

    Summary
    Times to peak plasma glucose and glucagon levels were similar under both intramuscular and intranasal conditions.
    3 context sentences
    Summary · context
    A total of 48 youth with type 1 diabetes completed the study at seven clinical centers.
    Summary · context
    Participants in the two youngest cohorts (4 to <8 and 8 to <12 years old) were randomly assigned to receive either 2 or 3 mg intranasal glucagon in two separate sessions or to receive a single, weight-based dose of intramuscular glucagon.
    Summary · context
    Participants aged 12 to <17 years received 1 mg intramuscular glucagon in one session and 3 mg intranasal glucagon in the other session.
  6. 06HumanNon-randomized trialPharmacokinetics

    In youth with type 1 diabetes, time to peak plasma glucagon was similar with intranasal and intramuscular glucagon.

    In plain wordsIn youth with type 1 diabetes, glucagon levels peaked at similar times with nasal and injected glucagon.

    Peptide
    Glucagon
    Outcome
    No significant changeTime to peak plasma glucagon
    Study

    n: not reported in source

    Comparator
    intramuscular glucagon
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    2 or 3 mg · intranasalAs given in this study (human).

    Source sentences

    Summary
    Times to peak plasma glucose and glucagon levels were similar under both intramuscular and intranasal conditions.
    3 context sentences
    Summary · context
    A total of 48 youth with type 1 diabetes completed the study at seven clinical centers.
    Summary · context
    Participants in the two youngest cohorts (4 to <8 and 8 to <12 years old) were randomly assigned to receive either 2 or 3 mg intranasal glucagon in two separate sessions or to receive a single, weight-based dose of intramuscular glucagon.
    Summary · context
    Participants aged 12 to <17 years received 1 mg intramuscular glucagon in one session and 3 mg intranasal glucagon in the other session.
  7. 07HumanNon-randomized trialSafety outcome

    In youth with type 1 diabetes, transient nausea occurred in 42% of intranasal versus 67% of intramuscular glucagon sessions (P = 0.05).

    In plain wordsIn youth with type 1 diabetes, transient nausea was less frequent with nasal than injected glucagon.

    Peptide
    Glucagon
    Outcome
    DecreaseTransient nausea
    Study

    n: not reported in source

    Comparator
    intramuscular glucagon
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    2 or 3 mg · intranasalAs given in this study (human).

    Measurements

    Sessions with transient nausea
    42%
    intranasal glucagon sessions
    Sessions with transient nausea
    67%
    intramuscular glucagon sessions

    Source sentences

    Summary
    Transient nausea occurred in 67% of intramuscular sessions versus 42% of intranasal sessions (P = 0.05)
    3 context sentences
    Summary · context
    A total of 48 youth with type 1 diabetes completed the study at seven clinical centers.
    Summary · context
    Participants in the two youngest cohorts (4 to <8 and 8 to <12 years old) were randomly assigned to receive either 2 or 3 mg intranasal glucagon in two separate sessions or to receive a single, weight-based dose of intramuscular glucagon.
    Summary · context
    Participants aged 12 to <17 years received 1 mg intramuscular glucagon in one session and 3 mg intranasal glucagon in the other session.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials2

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

2 trials · 2 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 4NCT05206149

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

A.O.U. Città della Salute e della Scienzan = 101 Oct 2021 to 31 Dec 2021

Hypopituitarism

Trial pageClinicalTrials.govUpdated 25 Jan 2022
CompletedPhase 2/3Results postedNCT01997411

Assessment of Intranasal Glucagon in Children and Adolescents With Type 1 Diabetes

Eli Lilly and Companyn = 48Nov 2013 to Jan 2015

Diabetes Mellitus, Type 1

Trial pageClinicalTrials.govUpdated 29 Aug 2018

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    28 Oct 2026, 02:03 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:35 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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