in Youth With Type 1 Diabetes

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in Youth With Type 1 Diabetes Glucagon Nasal Powder: A Promising Alternative to Intramuscular Glucagon in Youth With Type 1 Diabetes Featured Article: Jennifer L. Sherr, Katrina J. Ruedy, Nicole C. Foster, Claude A. Piché, Hélène Dulude, Michael R. Rickels, William V. Tamborlane, Kathleen E. Bethin, Linda A. DiMeglio, Larry A. Fox, R. Paul Wadwa, Desmond A. Schatz, Brandon M. Nathan, Santica M. Marcovina, Emmanouil Rampakakis, Linyan Meng, and Roy W. Beck, for the T1D Exchange Intranasal Glucagon Investigators Diabetes Care Volume 39: 555–562 April 2016

STUDY OBJECTIVE Treatment of severe hypoglycemia outside of the hospital setting is limited to intramuscular glucagon requiring reconstitution prior to injection. The current study examined the safety and dose-response relationships of a needle-free intranasal glucagon preparation in youth aged 4 to <17 years. Sherr J.L. et al. Diabetes Care 2016;39:555–562

STUDY DESIGN AND METHODS A total of 48 youth with type 1 diabetes completed the study at seven clinical centers. Participants in the two youngest cohorts (4 to <8 and 8 to <12 years old) were randomly assigned to receive either 2 or 3 mg intranasal glucagon in two separate sessions or to receive a single, weight-based dose of intramuscular glucagon. Participants aged 12 to <17 years received 1 mg intramuscular glucagon in one session and 3 mg intranasal glucagon in the other session. Glucagon was given after glucose was lowered to <80 mg/dL (mean nadir ranged between 67 and 75 mg/dL). Sherr J.L. et al. Diabetes Care 2016;39:555–562

RESULTS All 24 intramuscular and 58 of the 59 intranasal doses produced a ≥25 mg/dL rise in glucose from nadir within 20 min of dosing. Times to peak plasma glucose and glucagon levels were similar under both intramuscular and intranasal conditions. Transient nausea occurred in 67% of intramuscular sessions versus 42% of intranasal sessions (P = 0.05); the efficacy and safety of the 2- and 3-mg intranasal doses were similar in the youngest cohorts. Sherr J.L. et al. Diabetes Care 2016;39:555–562

Sherr J.L. et al. Diabetes Care 2016;39:555–562

Sherr J.L. et al. Diabetes Care 2016;39:555–562

Sherr J.L. et al. Diabetes Care 2016;39:555–562

Sherr J.L. et al. Diabetes Care 2016;39:555–562

Sherr J.L. et al. Diabetes Care 2016;39:555–562

CONCLUSIONS Results of this phase 1, pharmacokinetic, and pharmacodynamic study support the potential efficacy of a needle-free glucagon nasal powder delivery system for treatment of hypoglycemia in youth with type 1 diabetes. Given the similar frequency and transient nature of adverse effects of the 2- and 3-mg intranasal doses in the two youngest cohorts, a single 3-mg intranasal dose appears to be appropriate for use across the entire 4- to <17-year age range. Sherr J.L. et al. Diabetes Care 2016;39:555–562