NASAL GLUCAGON SUCCESSFULLY REVERSED INSULIN-INDUCED HYPOGLYCEMIA IN ADULTS WITH DIABETES WITH NADIR BLOOD GLUCOSE LESS THAN 3.0 MMOL/L (54 MG/DL): A POOLED ANALYSIS
- Pratik Choudhary, United Kingdom
- R. Paul Wadwa, United States of America
- Munehide Matsuhisa, Japan
- Nan Zhang, United States of America
- Vivian Thieu, United States of America
- Qianqian Wang, United States of America
- Kenji Ohwaki, United States of America
- Christopher J. Child, United States of America
- Rebecca J. Threlkeld, United States of America
- Pratik Choudhary, United Kingdom
Abstract
Background and Aims
Nasal glucagon (NG), a ready-to-use drug-device combination for treatment of severe hypoglycemia (SH), contains 3 mg glucagon dry powder that is absorbed through the nasal mucosa. We aimed to examine the efficacy and safety of NG in reversing clinically significant insulin-induced hypoglycemia in adults with diabetes.
Methods
Post-hoc analyses were performed to assess the efficacy and safety of NG compared to injectable glucagon (IG) using data from participants in 3 randomized studies whose nadir blood glucose (BG) was <3.0 mmol/L (54 mg/dL). The analysis included 169 adults (NG=156, IG=133). Treatment success was defined as an increase in BG to ≥3.9 mmol/L (70 mg/dL) or an increase of ≥1.1 mmol/L (20 mg/dL) from nadir BG within 30 min of receiving glucagon. Tolerability was assessed through reported treatment-emergent adverse events (TEAEs) and solicited using a Nasal and Non-Nasal Score Questionnaire.
Results
NG (99.4%) and IG (100%) successfully reversed clinically significant hypoglycemia, and the mean time to treatment success (preparation time excluded) was 14 min and 12 min, respectively (p<0.001). BG changes were similar between treatments (Figure). No serious AEs occurred. TEAEs with an incidence ≥10% for NG were nausea, vomiting, and headache. Worsening of nasal and non-nasal symptoms experienced by ≥10% of patients up to 60 min after NG included runny nose, nasal congestion, nasal itching, watery eyes, redness of eyes, and itchy eyes.
Conclusions
NG was efficacious and well tolerated in reversing clinically significant hypoglycemia in adults with diabetes, supporting NG as a rescue treatment for SH.