Nasal glucagon was noninferior to intramuscular glucagon for treating hypoglycemia in Japanese adults with type 1 or type 2 diabetes, according to findings published in Diabetes, Obesity and Metabolism.
“Because prolonged severe hypoglycemia is associated with complications such as
neurological and cardiovascular issues, coma and death, immediate recovery from severe
hypoglycemia is important in the emergent clinical setting,” Munehide Matsuhisa, MD, PhD, professor at the Diabetes Therapeutics Research Center of the Institute of Advanced Medical Sciences, Tokushima University, Japan, and colleagues wrote. “Because nasal glucagon is a ready-to-use treatment that does not require reconstitution, injection or patient inhalation (it is absorbed from the nasal cavity), it offers an appealing alternative to injectable glucagon for treatment of severe hypoglycemia occurring outside of a hospital setting. ... This study’s primary objective was to demonstrate ... treatment success during controlled insulin-induced hypoglycemia.”
Matsuhisa and colleagues enrolled 75 Japanese adults with type 1 diabetes (n = 33; 20 men; mean age, 41.7 years; 0 aged 60 years; mean diabetes duration, 13.3 years) or type 2 diabetes (n = 39; 30 men; mean age, 57.5 years; 13 aged 60 years) in a multicenter, randomized, open-label, crossover study, between February 2018 to August 2018; 68 participants completed the study. All participants were prescribed insulin and had an HbA1c of 10% or lower.
Participants were randomly assigned to 3 mg nasal glucagon or 1 mg intramuscular glucagon following hypoglycemia (plasma glucose level 60 mg/dL) induced with an IV insulin infusion; they received the other glucagon delivery method following a second induced hypoglycemia test. Glucagon was administered approximately 5 minutes after insulin was discontinued.
After hypoglycemia, all participants reached a plasma glucagon level of at least 70 mg/dL or 20 mg/dL increase from lowest level within 30 minutes after administration, which was defined as treatment success, with a mean time to treatment success of 12 minutes for nasal glucagon and 11 minutes for intramuscular glucagon. Both groups achieved treatment success by 25 minutes (treatment arm difference: 0%; upper limit of two-sided 95% CI, 1.47%), which was within predefined noninferiority for nasal glucagon.
“This study achieved its primary objective ... regarding the percentage of patients achieving treatment success following controlled insulin-induced hypoglycemia,” the researchers wrote. “These findings support the use of nasal glucagon 3 mg as a rescue treatment for severe hypoglycemia.” – by Kate Burba
Disclosures: Matsuhisa reports he receives research support from Boehringer Ingelheim, Nissui Pharmaceutical, Novartis, Novo Nordisk, Ono Pharmaceutical, Sysmex Corp., Takeda Pharmaceuticals and Tanabe-Mitsubishi Pharma Corp.; is a member of the speakers bureau for Astellas Pharma, Merck Sharp & Dohme, Novo Nordisk, Sanofi, Takeda Pharmaceuticals and Tanabe-Mitsubishi Pharma Corp.; and is an adviser to Eli Lilly Japan K.K. Please see the study for all other authors’ relevant financial disclosures.