LAUSR

Background: Nasal glucagon (NG), a ready-to-use drug-device combination for treatment of severe hypoglycemia, contains 3 mg glucagon dry powder that is absorbed passively through nasal mucosa. We examined the efficacy and safety of NG compared to 1 mg injectable glucagon (IG) in reversing insulin-induced hypoglycemia in a global population of adults with T1D or T2D. Notably, this is the first analysis including pooled T2D data. Methods: Post-hoc analyses used data from 3 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 30 min of receiving glucagon. Tolerability was assessed using treatment-emergent adverse events and a symptom questionnaire. Results: In the T1D+T2D pooled analysis, 99.5% (213/214) of NG and 100% (214/214) of IG patients achieved treatment success in a mean time (preparation time excluded) of 13 and 11 min, respectively. All NG T2D patients (N=41) achieved treatment success. NG and IG induced similar BG changes (Figure). NG and IG had similar incidences of nausea and vomiting, with NG having a higher rate of side effects related to nasal administration [headache (13% NG, 7% IG), nasal discomfort (4% NG, 1% IG), etc.]. Separate T1D and T2D analyses showed similar results as T1D+T2D. Conclusion: NG was efficacious and well-tolerated in reversing insulin-induced hypoglycemia in adults with T1D or T2D. Disclosure E.R. Seaquist: Advisory Panel; Self; MannKind Corporation, Zucara Therapeutics Inc. Other Relationship; Self; American Board of Internal Medicine, Endocrine Society, International Hypoglycemia Study Group. K. Khunti: Advisory Panel; Self; Amgen, AstraZeneca, Bayer AG, Berlin-Chemie AG, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Menarini Group, Merck Sharp & Dohme Corp., Napp Pharmaceuticals, Novartis AG, Novo Nordisk A/S, Roche Pharma, Sanofi-Aventis, Servier. Board Member; Self; AstraZeneca, Eli Lilly and Company, Merck Sharp & Dohme Corp., Novo Nordisk A/S, Sanofi-Aventis. Consultant; Self; Amgen, AstraZeneca, Bayer AG, Berlin-Chemie AG, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Menarini Group, Merck Sharp & Dohme Corp., Napp Pharmaceuticals, Novartis AG, Novo Nordisk A/S, Roche Pharma, Sanofi-Aventis, Servier. Research Support; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Merck Sharp & Dohme Corp., Novartis AG, Novo Nordisk A/S, Pfizer Inc., Sanofi-Aventis, Servier. Speaker’s Bureau; Self; Amgen, AstraZeneca, Bayer AG, Berlin-Chemie AG, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Menarini Group, Merck Sharp & Dohme Corp., Napp Pharmaceuticals, Novartis AG, Novo Nordisk A/S, Roche Pharma, Sanofi-Aventis, Servier. M.X. Zhang: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company. Q. Wang: Employee; Self; Eli Lilly and Company. Y. Takita: Employee; Self; Eli Lilly Japan K.K. C.J. Child: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company. Y. Nagai: Employee; Self; Eli Lilly Japan K.K. Stock/Shareholder; Self; Eli Lilly and Company. Y. Yan: Employee; Self; Eli Lilly and Company. M. Matsuhisa: Research Support; Self; Daiichi Sankyo, Mitsubishi Tanabe Pharma Corporation, Novartis Pharma K.K., Novo Nordisk Inc., Sanofi, Sysmex Corporation. Speaker’s Bureau; Self; Astellas Pharma Inc., Eli Lilly Japan K.K., Merck Sharp & Dohme Corp., Mitsubishi Tanabe Pharma Corporation, Novo Nordisk Inc., Sanofi K.K., Takeda Pharmaceutical Company Limited. Funding Eli Lilly and Company