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Study · Randomized controlled trial · n = 68 · 2020

11 results

Nasal glucagon as a viable alternative for treating insulin-induced hypoglycaemia in Japanese patients with type 1 or type 2 diabetes: A phase 3 randomized crossover study.

Matsuhisa M, Takita Y, Nasu R, Nagai Y, Ohwaki K, Nagashima H

Diabetes, obesity & metabolism12 Apr 2020Cited by 23 (Europe PMC)

PMID32115879 (opens in a new tab)PMCIDPMC7318639 (opens in a new tab)DOI10.1111/dom.14019 (opens in a new tab)PepBankPUB-32115879
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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: CC BY-NC. Results still quote short attributed sentences.

Results from this study11

11 results from studies that gave the peptide. 11 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In Japanese adults with diabetes, all evaluable patients achieved success with either glucagon route, meeting non-inferiority criteria (difference 0%, upper confidence limit 1.47%).

    In plain wordsIn Japanese adults with diabetes, nasal glucagon met non-inferiority criteria versus intramuscular glucagon for successful treatment.

    Peptide
    Glucagon
    Outcome
    No significant changeTreatment success
    Study

    n = 68

    Comparator
    Intramuscular glucagon 1 mg
    Analysis
    Primary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    3 mg · nasalAs given in this study (human).

    Measurements

    Treatment arm difference in treatment success (IMG minus NG)
    0%
    nasal versus intramuscular glucagon
    Upper limit of two-sided 95% CI of the difference
    1.47%
    nasal versus intramuscular glucagon

    Source sentences

    Summary
    All NG- and IMG-treated patients achieved treatment success (treatment arm difference: 0%; upper limit of two-sided 95% CI 1.47%); NG met prespecified conditions defining non-inferiority versus IMG.
    3 context sentences
    Summary · context
    Sixty-eight patients completed the study and were evaluable.
    Summary · context
    This phase 3, randomized, open-label, two-treatment, two-period crossover non-inferiority study enrolled Japanese adults with T1DM or T2DM on insulin therapy, with glycated haemoglobin levels ≤86 mmol/mol (≤10%).
    Summary · context
    Patients received NG 3 mg or IMG 1 mg approximately 5 minutes after insulin termination.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In Japanese adults with diabetes, glucose profiles were similar after nasal and intramuscular glucagon during the first 60 minutes.

    In plain wordsIn Japanese adults with diabetes, glucose profiles were similar with nasal and intramuscular glucagon during the first 60 minutes.

    Peptide
    Glucagon
    Outcome
    No significant changePlasma glucose profile
    Study

    n: not reported in source

    Comparator
    Intramuscular glucagon 1 mg
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    3 mg · nasalAs given in this study (human).

    Source sentences

    Summary
    Glucagon was rapidly absorbed after both nasal and intramuscular administration; PG profiles were similar between administration routes during the first 60 minutes post dose.
    2 context sentences
    Summary · context
    This phase 3, randomized, open-label, two-treatment, two-period crossover non-inferiority study enrolled Japanese adults with T1DM or T2DM on insulin therapy, with glycated haemoglobin levels ≤86 mmol/mol (≤10%).
    Summary · context
    Patients received NG 3 mg or IMG 1 mg approximately 5 minutes after insulin termination.
  3. 03HumanNon-randomized trialPharmacokinetics

    In Japanese adults with diabetes, nasal glucagon was rapidly absorbed.

    In plain wordsIn Japanese adults with diabetes, nasal glucagon entered the bloodstream rapidly.

    Peptide
    Glucagon
    Outcome
    Not applicableRapid absorption: nasal glucagon
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    3 mg · nasalAs given in this study (human).

    Source sentences

    Summary
    Glucagon was rapidly absorbed after both nasal and intramuscular administration; PG profiles were similar between administration routes during the first 60 minutes post dose.
    2 context sentences
    Summary · context
    This phase 3, randomized, open-label, two-treatment, two-period crossover non-inferiority study enrolled Japanese adults with T1DM or T2DM on insulin therapy, with glycated haemoglobin levels ≤86 mmol/mol (≤10%).
    Summary · context
    Patients received NG 3 mg or IMG 1 mg approximately 5 minutes after insulin termination.
  4. 04HumanNon-randomized trialPharmacokinetics

    In Japanese adults with diabetes, intramuscular glucagon was rapidly absorbed.

    In plain wordsIn Japanese adults with diabetes, injected glucagon entered the bloodstream rapidly.

    Peptide
    Glucagon
    Outcome
    Not applicableRapid absorption: intramuscular glucagon
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    1 mg · intramuscularAs given in this study (human).

    Source sentences

    Summary
    Glucagon was rapidly absorbed after both nasal and intramuscular administration; PG profiles were similar between administration routes during the first 60 minutes post dose.
    2 context sentences
    Summary · context
    This phase 3, randomized, open-label, two-treatment, two-period crossover non-inferiority study enrolled Japanese adults with T1DM or T2DM on insulin therapy, with glycated haemoglobin levels ≤86 mmol/mol (≤10%).
    Summary · context
    Patients received NG 3 mg or IMG 1 mg approximately 5 minutes after insulin termination.
  5. 05HumanNon-randomized trialSafety outcome

    In Japanese adults with diabetes, glucagon-related rhinalgia affected >2 patients in the nasal group.

    In plain wordsIn Japanese adults with diabetes, more than two patients had nose pain related to nasal glucagon.

    Peptide
    Glucagon
    Outcome
    Not applicableRhinalgia: nasal glucagon
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    3 mg · nasalAs given in this study (human).

    Source sentences

    Summary
    Study drug-related treatment-emergent adverse events affecting >2 patients were rhinalgia, increased blood pressure, nausea, ear pain and vomiting in the NG group, and nausea and vomiting in the IMG group.
    2 context sentences
    Summary · context
    This phase 3, randomized, open-label, two-treatment, two-period crossover non-inferiority study enrolled Japanese adults with T1DM or T2DM on insulin therapy, with glycated haemoglobin levels ≤86 mmol/mol (≤10%).
    Summary · context
    Patients received NG 3 mg or IMG 1 mg approximately 5 minutes after insulin termination.
  6. 06HumanNon-randomized trialSafety outcome

    In Japanese adults with diabetes, glucagon-related increased blood pressure affected >2 patients in the nasal group.

    In plain wordsIn Japanese adults with diabetes, more than two patients had increased blood pressure related to nasal glucagon.

    Peptide
    Glucagon
    Outcome
    Not applicableIncreased blood pressure: nasal glucagon
    Study

    n: not reported in source

    Outcome group
    Blood pressure · Cardiovascular
    Studied dose
    3 mg · nasalAs given in this study (human).

    Source sentences

    Summary
    Study drug-related treatment-emergent adverse events affecting >2 patients were rhinalgia, increased blood pressure, nausea, ear pain and vomiting in the NG group, and nausea and vomiting in the IMG group.
    2 context sentences
    Summary · context
    This phase 3, randomized, open-label, two-treatment, two-period crossover non-inferiority study enrolled Japanese adults with T1DM or T2DM on insulin therapy, with glycated haemoglobin levels ≤86 mmol/mol (≤10%).
    Summary · context
    Patients received NG 3 mg or IMG 1 mg approximately 5 minutes after insulin termination.
  7. 07HumanNon-randomized trialSafety outcome

    In Japanese adults with diabetes, glucagon-related nausea affected >2 patients in the nasal group.

    In plain wordsIn Japanese adults with diabetes, more than two patients had nausea related to nasal glucagon.

    Peptide
    Glucagon
    Outcome
    Not applicableNausea: nasal glucagon
    Study

    n: not reported in source

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    3 mg · nasalAs given in this study (human).

    Source sentences

    Summary
    Study drug-related treatment-emergent adverse events affecting >2 patients were rhinalgia, increased blood pressure, nausea, ear pain and vomiting in the NG group, and nausea and vomiting in the IMG group.
    2 context sentences
    Summary · context
    This phase 3, randomized, open-label, two-treatment, two-period crossover non-inferiority study enrolled Japanese adults with T1DM or T2DM on insulin therapy, with glycated haemoglobin levels ≤86 mmol/mol (≤10%).
    Summary · context
    Patients received NG 3 mg or IMG 1 mg approximately 5 minutes after insulin termination.
  8. 08HumanNon-randomized trialSafety outcome

    In Japanese adults with diabetes, glucagon-related ear pain affected >2 patients in the nasal group.

    In plain wordsIn Japanese adults with diabetes, more than two patients had ear pain related to nasal glucagon.

    Peptide
    Glucagon
    Outcome
    Not applicableEar pain: nasal glucagon
    Study

    n: not reported in source

    Outcome group
    Pain · Whole body
    Studied dose
    3 mg · nasalAs given in this study (human).

    Source sentences

    Summary
    Study drug-related treatment-emergent adverse events affecting >2 patients were rhinalgia, increased blood pressure, nausea, ear pain and vomiting in the NG group, and nausea and vomiting in the IMG group.
    2 context sentences
    Summary · context
    This phase 3, randomized, open-label, two-treatment, two-period crossover non-inferiority study enrolled Japanese adults with T1DM or T2DM on insulin therapy, with glycated haemoglobin levels ≤86 mmol/mol (≤10%).
    Summary · context
    Patients received NG 3 mg or IMG 1 mg approximately 5 minutes after insulin termination.
  9. 09HumanNon-randomized trialSafety outcome

    In Japanese adults with diabetes, glucagon-related vomiting affected >2 patients in the nasal group.

    In plain wordsIn Japanese adults with diabetes, more than two patients had vomiting related to nasal glucagon.

    Peptide
    Glucagon
    Outcome
    Not applicableVomiting: nasal glucagon
    Study

    n: not reported in source

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    3 mg · nasalAs given in this study (human).

    Source sentences

    Summary
    Study drug-related treatment-emergent adverse events affecting >2 patients were rhinalgia, increased blood pressure, nausea, ear pain and vomiting in the NG group, and nausea and vomiting in the IMG group.
    2 context sentences
    Summary · context
    This phase 3, randomized, open-label, two-treatment, two-period crossover non-inferiority study enrolled Japanese adults with T1DM or T2DM on insulin therapy, with glycated haemoglobin levels ≤86 mmol/mol (≤10%).
    Summary · context
    Patients received NG 3 mg or IMG 1 mg approximately 5 minutes after insulin termination.
  10. 10HumanNon-randomized trialSafety outcome

    In Japanese adults with diabetes, glucagon-related nausea affected >2 patients in the intramuscular group.

    In plain wordsIn Japanese adults with diabetes, more than two patients had nausea related to injected glucagon.

    Peptide
    Glucagon
    Outcome
    Not applicableNausea: intramuscular glucagon
    Study

    n: not reported in source

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    1 mg · intramuscularAs given in this study (human).

    Source sentences

    Summary
    Study drug-related treatment-emergent adverse events affecting >2 patients were rhinalgia, increased blood pressure, nausea, ear pain and vomiting in the NG group, and nausea and vomiting in the IMG group.
    2 context sentences
    Summary · context
    This phase 3, randomized, open-label, two-treatment, two-period crossover non-inferiority study enrolled Japanese adults with T1DM or T2DM on insulin therapy, with glycated haemoglobin levels ≤86 mmol/mol (≤10%).
    Summary · context
    Patients received NG 3 mg or IMG 1 mg approximately 5 minutes after insulin termination.
  11. 11HumanNon-randomized trialSafety outcome

    In Japanese adults with diabetes, glucagon-related vomiting affected >2 patients in the intramuscular group.

    In plain wordsIn Japanese adults with diabetes, more than two patients had vomiting related to injected glucagon.

    Peptide
    Glucagon
    Outcome
    Not applicableVomiting: intramuscular glucagon
    Study

    n: not reported in source

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    1 mg · intramuscularAs given in this study (human).

    Source sentences

    Summary
    Study drug-related treatment-emergent adverse events affecting >2 patients were rhinalgia, increased blood pressure, nausea, ear pain and vomiting in the NG group, and nausea and vomiting in the IMG group.
    2 context sentences
    Summary · context
    This phase 3, randomized, open-label, two-treatment, two-period crossover non-inferiority study enrolled Japanese adults with T1DM or T2DM on insulin therapy, with glycated haemoglobin levels ≤86 mmol/mol (≤10%).
    Summary · context
    Patients received NG 3 mg or IMG 1 mg approximately 5 minutes after insulin termination.

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

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

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