Response to Comment on Rickels et al. Intranasal Glucagon for Treatment of Insulin-Induced Hypoglycemia in Adults With Type 1 Diabetes: A Randomized Crossover Noninferiority Study. Diabetes Care 2016;39:264–270

Abstract

We thank Munoz et al. (1) for the opportunity to provide additional rationale for the study design and interpretation of the data supporting the noninferiority of intranasal glucagon for treatment of insulin-induced hypoglycemia. Our study (2) was not designed to test recovery from severe hypoglycemia but rather recovery from insulin-induced hypoglycemia that ethically may only be produced under the controlled conditions available in a clinical research center. Intranasal glucagon was effective in correcting insulin-induced hypoglycemia, and when considering only those subjects with nadir glucose concentrations <50 mg/dL, the average time to achieving a glucose concentration of 70 mg/dL or a 20 mg/dL increase was 16 min compared with 13 min with intramuscular glucagon (2). We make no claims that intranasal glucagon and intramuscular glucagon are “equally” effective. The noninferiority margin of 10% was chosen on the basis of the data for glucagon injection in a simulated emergency study where 10% of participants (parents of children and adolescents with type 1 diabetes) entirely failed to administer the injectable glucagon product (3). Despite …