Intranasal Glucagon for Treatment of Insulin-Induced Hypoglycemia in Adults With Type 1 Diabetes: A Randomized Crossover Noninferiority Study.

Rickels MR, Ruedy KJ, Foster NC, Piché CA, Dulude H, Sherr JL, Tamborlane WV, Bethin KE, DiMeglio LA, Wadwa RP, Ahmann AJ, Haller MJ and 5 more

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

Diabetes care17 Dec 2015Cited by 85 (Europe PMC)

PMID26681725PMCIDPMC4722945DOI10.2337/dc15-1498PepBankPUB-26681725

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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 study4

4 results from studies that gave the peptide. 4 results from people.

01HumanRandomized controlled trialEfficacy outcome
In adults with type 1 diabetes, treatment success occurred in 98.7% of intranasal versus 100% of intramuscular glucagon visits.
In plain wordsIn adults with type 1 diabetes, intranasal glucagon succeeded at 98.7% of visits compared with 100% for intramuscular glucagon.
Peptide
Glucagon
Outcome
Not applicableTreatment success
Study
n = 75
Comparator
1 mg intramuscular glucagon
Outcome group
Glycemic control · Metabolic and weight
Studied dose
3 mg · intranasalAs given in this study (human).
Measurements
Treatment success
98.7%
intranasal
Treatment success
100%
intramuscular
Difference
1.3%
between routes
Upper one-sided 97.5% CI
4%
difference
Source sentences
Summary
Success criteria were met at all but one intranasal visit and at all intramuscular visits (98.7% vs. 100%; difference 1.3%, upper end of 1-sided 97.5% CI 4.0%).
2 context sentences(design, population, supporting numbers)
Summary · context
Success was defined as an increase in plasma glucose to ≥70 mg/dL or ≥20 mg/dL from the glucose nadir within 30 min after receiving glucagon.
Summary · context
At eight clinical centers, a randomized crossover noninferiority trial was conducted involving 75 adults with type 1 diabetes (mean age, 33 ± 12 years; median diabetes duration, 18 years) to compare intranasal (3 mg) versus intramuscular (1 mg) glucagon for treatment of hypoglycemia induced by intravenous insulin.
Report a problemFND-2668172501
02HumanRandomized controlled trialEfficacy outcome
In adults with type 1 diabetes, mean time to success was 16 minutes for intranasal versus 13 minutes for intramuscular glucagon.
In plain wordsIn adults with type 1 diabetes, intranasal glucagon took 16 minutes on average to succeed compared with 13 minutes for intramuscular glucagon.
Peptide
Glucagon
Outcome
IncreaseTime to treatment success
Study
n = 75
Comparator
1 mg intramuscular glucagon
Outcome group
Glycemic control · Metabolic and weight
Studied dose
3 mg · intranasalAs given in this study (human).
Measurements
Mean time to success
16 min
intranasal
Mean time to success
13 min
intramuscular
P value
< 0.001
between routes
Source sentences
Summary
Mean time to success was 16 min for intranasal and 13 min for intramuscular (P < 0.001).
1 context sentence(design, population, supporting numbers)
Summary · context
At eight clinical centers, a randomized crossover noninferiority trial was conducted involving 75 adults with type 1 diabetes (mean age, 33 ± 12 years; median diabetes duration, 18 years) to compare intranasal (3 mg) versus intramuscular (1 mg) glucagon for treatment of hypoglycemia induced by intravenous insulin.
Report a problemFND-2668172502
03HumanRandomized controlled trialSafety outcome
In adults with type 1 diabetes, head or facial discomfort occurred in 25% of intranasal versus 9% of intramuscular glucagon visits.
In plain wordsIn adults with type 1 diabetes, head or facial discomfort occurred more often with intranasal than intramuscular glucagon.
Peptide
Glucagon
Outcome
IncreaseHead or facial discomfort
Study
n = 75
Comparator
1 mg intramuscular glucagon
Outcome group
Adverse events · Whole body
Studied dose
3 mg · intranasalAs given in this study (human).
Measurements
Head/facial discomfort
25%
intranasal visits
Head/facial discomfort
9%
intramuscular visits
Source sentences
Summary
Head/facial discomfort was reported during 25% of intranasal and 9% of intramuscular dosing visits; nausea (with or without vomiting) occurred with 35% and 38% of visits, respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
At eight clinical centers, a randomized crossover noninferiority trial was conducted involving 75 adults with type 1 diabetes (mean age, 33 ± 12 years; median diabetes duration, 18 years) to compare intranasal (3 mg) versus intramuscular (1 mg) glucagon for treatment of hypoglycemia induced by intravenous insulin.
Report a problemFND-2668172503
04HumanRandomized controlled trialSafety outcome
In adults with type 1 diabetes, nausea with or without vomiting occurred in 35% of intranasal versus 38% of intramuscular glucagon visits.
In plain wordsIn adults with type 1 diabetes, nausea with or without vomiting occurred in 35% of intranasal versus 38% of intramuscular glucagon visits.
Peptide
Glucagon
Outcome
DecreaseNausea with or without vomiting
Study
n = 75
Comparator
1 mg intramuscular glucagon
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
3 mg · intranasalAs given in this study (human).
Measurements
Nausea with or without vomiting
35%
intranasal visits
Nausea with or without vomiting
38%
intramuscular visits
Source sentences
Summary
Head/facial discomfort was reported during 25% of intranasal and 9% of intramuscular dosing visits; nausea (with or without vomiting) occurred with 35% and 38% of visits, respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
At eight clinical centers, a randomized crossover noninferiority trial was conducted involving 75 adults with type 1 diabetes (mean age, 33 ± 12 years; median diabetes duration, 18 years) to compare intranasal (3 mg) versus intramuscular (1 mg) glucagon for treatment of hypoglycemia induced by intravenous insulin.
Report a problemFND-2668172504

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

Registered trials1

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

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

CompletedPhase 3Results postedNCT01994746

Efficacy and Safety of Nasal Glucagon for Treatment of Hypoglycemia in Adults

Eli Lilly and Companyn = 77Nov 2013 to Jan 2015

Diabetes Mellitus, Type 1

Trial page ClinicalTrials.govUpdated 23 Sept 2019

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.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
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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