Background: Nasal glucagon (NG), a ready-to-use therapy for treatment of severe hypoglycemia, contains 3 mg glucagon dry powder absorbed passively through nasal mucosa. We evaluated efficacy, pharmacodynamics (PD), and safety of NG compared to injectable glucagon (IG) in reversing insulin-induced hypoglycemia in Caucasian and Japanese adults with T1D or T2D.
Methods: Post-hoc analyses used data from 2 randomized, cross-over studies. Treatment success was defined as an increase in BG to ≥70 mg/dL or an increase of ≥20 mg/dL from nadir BG within 15 min of receiving glucagon. PD data, including area under the curve above 140 mg/dl [∆140 AUC (1-4 hr)], were used to evaluate the risk of secondary hyperglycemia. Tolerability was assessed with treatment-emergent adverse events and a symptom questionnaire.
Results: A similar proportion of NG [97.8% (131/134)] and IG patients [97.0% (130/134)] achieved treatment success. Geometric least square mean BGmax for NG and IG were 194 and 205 mg/dL (p<0.001), respectively. NG had significantly lower ∆140 AUC (1-4 hr) (p<0.001). NG had similar rates of nausea and vomiting versus IG, with higher rates of side effects related to nasal administration.
Conclusions: NG was efficacious and well-tolerated in reversing insulin-induced hypoglycemia in adults with T1D or T2D and did not increase the risk of secondary hyperglycemia compared to IG.
Y. Yan: Employee; Self; Eli Lilly and Company. Q. Wang: Employee; Self; Eli Lilly and Company. C.J. Child: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company. M.X. Zhang: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company.
Eli Lilly and Company