Baqsimi® (glukagon näspulver): Insulinpumpar

Adult Pivotal Study

One of the pivotal studies, Study 2, was a randomized, multicenter, open-label, crossover study that evaluated NG 3 mg compared with injectable glucagon 1 mg administered IM as treatment for insulin-induced hypoglycemia in adults with T1DM or T2DM.¹

In this pivotal study in adults, insulin pumps were used by 57 (74%) participants with T1DM.¹

Adult Real-World Use Study

A phase 3, open-label, multicenter, single-arm study evaluated the effectiveness and ease of use of NG 3 mg in the treatment of moderate or severe hypoglycemic events in adults (aged 18 to 75 years) with T1DM in a real-world setting (home or work).²

In the real-world use study in adults with T1DM, insulin pumps were used by 72 (55.8%) participants.³

Pediatric Pivotal Study

A randomized, multicenter, dose finding clinical study evaluated the ability of NG 2 mg and 3 mg doses compared with injectable glucagon 0.5 mg or 1.0 mg (based on body weight) administered IM to increase the BG after insulin-induced reduction in BG in children and adolescents (aged 4 to <17 years) with T1DM.⁴

In the pivotal study in children and adolescents with T1DM, insulin pumps were used by

• 10 (56%) participants between 4 years and less than 8 years of age

• 16 (89%) participants between 8 years and less than 12 years of age, and

• 9 (75%) participants between 12 years and less than 17 years of age.⁴

References

1. Rickels MR, Ruedy KJ, Foster NC, et al; T1D Exchange Intranasal Glucagon Investigators. Intranasal glucagon for treatment of insulin-induced hypoglycemia in adults with type 1 diabetes: a randomized crossover noninferiority study. Diabetes Care. 2016;39(2):264-270. https://doi.org/10.2337/dc15-1498

2. 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

3. Seaquist ER, Dulude H, Zhang MX et al. Nasal glucagon for the treatment of moderate-to-severe hypoglycaemic episodes in real-world settings in adults with type 1 diabetes. Poster presented at: 53rd European Association for the Study of Diabetes (EASD): September 11-15, 2017; Lisbon, Portugal.

4. Sherr JL, Ruedy KJ, Foster NC, et al; T1D Exchange Intranasal Glucagon Investigators. Glucagon nasal powder: a promising alternative to intramuscular glucagon in youth with type 1 diabetes. Diabetes Care. 2016;39(4):555-562. https://doi.org/10.2337/dc15-1606

Glossary

BG = blood glucose

IM = intramuscular

NG = nasal glucagon (glucagon nasal powder)

T1DM = type 1 diabetes mellitus

T2DM = type 2 diabetes mellitus