Baqsimi® (glukagon näspulver): Tid till administrering

Summary Information

The results from a simulated severe hypoglycemia rescue study showed that Nasal Glucagon was administered faster than glucagon administered IM by both instructed caregivers and non-instructed acquaintances.¹

In real-world use studies, caregivers administered Nasal Glucagon within 30 seconds in 70.4% of the moderate or severe hypoglycemic events in the adult population and in 60.6% of the moderate hypoglycemic events in the pediatric population.^2,3

In real-world use studies, caregivers administered Nasal Glucagon within 2 minutes in 97.7% of the moderate or severe hypoglycemic events in the adult population and in 100% of the moderate hypoglycemic events in the pediatric population.^2,3

Simulated Severe Hypoglycemia Rescue Study

The rates of successful administration of Nasal Glucagon were compared with those of injectable glucagon administered IM in treating simulated episodes of severe hypoglycemia in a mannequin, which represented an unconscious person with DM.¹

The study compared the ability of Nasal Glucagon and IM glucagon to be administered by

• instructed primary caregivers who received verbal instructions from a paired person with DM, and

• non-instructed acquaintances who were only shown the study glucagon but were not instructed.¹

The study drugs were administered under conditions of distracting sounds and other stressors that were used to simulate urgency and stress in real-life emergency situations.¹

The time to administer each study glucagon dose was one of the outcomes evaluated.¹

Delivery Time

The mean time to administer Nasal Glucagon was less than the time required to administer IM glucagon in both the instructed caregivers and non-instructed acquaintances groups ( ).¹

Table 1. Time to Administer Nasal Glucagon or IM Glucagon by Instructed Caregivers and Non-Instructed Acquaintances¹

Abbreviations: IM = intramuscular glucagon; NG = nasal glucagon (glucagon nasal powder).

^a Includes data in which full or partial doses of glucagon were administered.

Real-World Use Studies in Adults and Pediatrics

Two phase 3, open-label, multicenter, single-arm studies evaluated the effectiveness and ease of use of Nasal Glucagon 3 mg in the treatment of moderate or severe hypoglycemic events in T1DM participants in a real-world use setting.^2,3

One study was in adults (aged 18 to 75 years) in a real-world use setting of home or work,³ and one study was in children and adolescents (aged 4 to <18 years) in a real-world use setting of home or school.²

Participants and caregivers were trained to administer Nasal Glucagon.^2,3 

The adult study included 69 participants who experienced 157 moderate or severe hypoglycemic events.³ The pediatric study included 14 children or adolescents who experienced 33 moderate hypoglycemic events and no severe hypoglycemic events.²

Delivery Time

Caregivers administered Nasal Glucagon within 30 seconds in

• 70.4% of the moderate or severe hypoglycemic events in the adult population, and

• 60.6% of the moderate hypoglycemic events in the pediatric population (no severe hypoglycemic events occurred).^2,3

Caregivers administered Nasal Glucagon within 2 minutes in

• 97.7% of the moderate or severe hypoglycemic events in the adult population, and

• 100% of the moderate hypoglycemic events in the pediatric population (no severe hypoglycemic events occurred).^2,3

References

1. Yale JF, Dulude H, Egeth M, et al. Faster use and fewer failures with needle-free nasal glucagon versus injectable glucagon in severe hypoglycemia rescue: a simulation study. Diabetes Technol Ther. 2017;19(7):423-432. https://doi.org/10.1089/dia.2016.0460

2. Deeb LC, Dulude H, Guzman CB, et al. A phase 3 multicenter, open-label, prospective study designed to evaluate the effectiveness and ease of use of nasal glucagon in the treatment of moderate and severe hypoglycemia in children and adolescents with type 1 diabetes in the home or school setting. Pediatr Diabetes. 2018;19(5):1007-1013. https://doi.org/10.1111/pedi.12668

3. Seaquist ER, Dulude H, Zhang XM, et al. Prospective study evaluating the use of nasal glucagon for the treatment of moderate to severe hypoglycaemia in adults with type 1 diabetes in a real-world setting. Diabetes Obes Metab. 2018;20(5):1316-1320. https://doi.org/10.1111/dom.13278

Glossary

DM = diabetes mellitus

IM = intramuscular

NG = nasal glucagon (glucagon nasal powder)