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ID 115085
Author
Takita, Yasushi Eli Lilly Japan
Nasu, Risa Eli Lilly Japan
Nagai, Yukiko Eli Lilly Japan
Ohwaki, Kenji Eli Lilly Japan
Nagashima, Hirotaka Shinjuku Research Park Clinic
Keywords
glucagon
hypoglycaemia
pharmacodynamics
pharmacokinetics
type 1 diabetes
type 2 diabetes
Content Type
Journal Article
Description
Aim: To compare nasal glucagon (NG) with intramuscular glucagon (IMG) for the treatment of insulin‐induced hypoglycaemia in Japanese patients with type 1 (T1DM) or type 2 diabetes mellitus (T2DM).
Materials and methods: 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%). After ≥8 hours of fasting, hypoglycaemia was induced with human regular insulin (intravenous infusion). Patients received NG 3 mg or IMG 1 mg approximately 5 minutes after insulin termination. The primary endpoint was the proportion of patients achieving treatment success [plasma glucose (PG) increase to ≥3.9 mmol/L (≥70 mg/dL) or ≥1.1 mmol/L (≥20 mg/dL) increase from the PG nadir within 30 minutes of receiving glucagon]. Non‐inferiority was declared if the upper limit of the two‐sided 95% confidence interval (CI) of the mean difference in the percentage of patients achieving treatment success (IMG minus NG) was <10%.
Results: Seventy‐five patients with T1DM (n = 34) or T2DM (n = 41) were enrolled; 72 patients (50 men, 22 women) received ≥1 study drug dose (T1DM, n = 33; T2DM, n = 39). Sixty‐eight patients completed the study and were evaluable. 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. Glucagon was rapidly absorbed after both nasal and intramuscular administration; PG profiles were similar between administration routes during the first 60 minutes post dose. 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.
Conclusion: Nasal glucagon was non‐inferior to IMG for successful treatment of insulin‐induced hypoglycaemia in Japanese patients with T1DM/T2DM, supporting use of NG as a rescue treatment for severe hypoglycaemia.
Journal Title
Diabetes, Obesity and Metabolism: A Journal of Pharmacology and Therapeutics
ISSN
14631326
NCID
AA11435496
Publisher
John Wiley & Sons
Volume
22
Issue
7
Start Page
1167
End Page
1175
Published Date
2020-03-01
Rights
This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License(https://creativecommons.org/licenses/by-nc/4.0/), which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
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DOI (Published Version)
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language
eng
TextVersion
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departments
Institute of Advanced Medical Sciences