Baqsimi ® (glukagon näspulver)

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Baqsimi® (glukagon näspulver): Tid till administrering

Genomsnittlig tid till administrering av glukagon näspulver var kortare jämfört med injicerbart glukagon i en studie av räddning vid simulerad allvarlig hypoglykemi och i studier av användning i verkliga livet.

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

Parameters

Instructed Caregivers

Instructed Caregivers

Non-Instructed Acquaintances

Non-Instructed Acquaintances

NG

IM

NG

IM

Average time to deliver dosea, minutes

0.27

1.89

0.44

2.40

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)

Datum fӧr senaste ӧversyn 2019 M07 24


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