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Diabetes Care. 2016 Feb;39(2):264-70. doi: 10.2337/dc15-1498. Epub 2015 Dec 17.

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

Author information

1
University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.
2
Jaeb Center for Health Research, Tampa, FL.
3
Jaeb Center for Health Research, Tampa, FL t1dstats@jaeb.org.
4
Locemia Solutions ULC, Montreal, QC, Canada.
5
Yale School of Medicine, New Haven, CT.
6
Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, The State University of New York, Buffalo, NY.
7
Indiana University School of Medicine, Indianapolis, IN.
8
Barbara Davis Center for Childhood Diabetes, Aurora, CO.
9
Harold Schnitzer Diabetes Health Center, Oregon Health & Science University, Portland, OR.
10
University of Florida, Gainesville, FL.
11
University of Minnesota, Minneapolis, MN.
12
Northwest Lipid Metabolism and Diabetes Research Laboratories, Seattle, WA.
13
JSS Medical Research, St. Laurent, QC, Canada.

Abstract

OBJECTIVE:

Treatment of severe hypoglycemia with loss of consciousness or seizure outside of the hospital setting is presently limited to intramuscular glucagon requiring reconstitution immediately prior to injection, a process prone to error or omission. A needle-free intranasal glucagon preparation was compared with intramuscular glucagon for treatment of insulin-induced hypoglycemia.

RESEARCH DESIGN AND METHODS:

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. 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.

RESULTS:

Mean plasma glucose at time of glucagon administration was 48 ± 8 and 49 ± 8 mg/dL at the intranasal and intramuscular visits, respectively. 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%). Mean time to success was 16 min for intranasal and 13 min for intramuscular (P < 0.001). 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.

CONCLUSIONS:

Intranasal glucagon was highly effective in treating insulin-induced hypoglycemia in adults with type 1 diabetes. Although the trial was conducted in a controlled setting, the results are applicable to real-world management of severe hypoglycemia, which occurs owing to excessive therapeutic insulin relative to the impaired or absent endogenous glucagon response.

PMID:
26681725
PMCID:
PMC4722945
DOI:
10.2337/dc15-1498
[Indexed for MEDLINE]
Free PMC Article

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