Table 2.
4 to <8 years old | 8 to <12 years old | 12 to <17 years old | ||||||
---|---|---|---|---|---|---|---|---|
IM |
2 mg IN |
3 mg IN |
IM |
2 mg IN |
3 mg IN |
IM |
3 mg IN |
|
N | 6 | 12 | 12 | 6 | 11 | 12 | 12 | 12 |
Plasma glucose at nadir (mg/dL)a | 71 ± 8 | 68 ± 9 | 67 ± 10 | 72 ± 12 | 75 ± 7 | 71 ± 6 | 69 ± 11 | 73 ± 9 |
Plasma glucose immediately prior to glucagon administration ≤70 mg/dL | 3 (50) | 6 (50) | 7 (58) | 1 (17) | 3 (27) | 6 (50) | 7 (58) | 1 (8) |
≥25 mg/dL rise in glucose by 20 minc | 6 (100) | 11 (92) | 12 (100) | 6 (100) | 11 (100) | 12 (100) | 12 (100) | 12 (100) |
Time until all participants experienced rise in glucose ≥25 mg/dL (min)d | 10 | 20 | 15 | 20 | 20 | 15 | 20 | 20 |
Mean rise in plasma glucose at 20 min (mg/dL) | 77 ± 10 | 60 ± 31 | 70 ± 20 | 49 ± 13 | 64 ± 11 | 67 ± 15 | 54 ± 14 | 41 ± 10 |
Maximum plasma glucose (mg/dL)b | 211 ± 27 | 189 ± 54 | 208 ± 44 | 205 ± 24 | 201 ± 28 | 206 ± 32 | 194 ± 33 | 178 ± 27 |
Cmax glucagon (pg/mL) | 6,343 ± 2,029 | 3,531 ± 1,762 | 4,033 ± 2,435 | 4,817 ± 3,086 | 2,952 ± 1,024 | 5,832 ± 2,106 | 4,382 ± 3,771 | 3,186 ± 2,294 |
Tmax glucagon (min) | 17 (5, 30) | 15 (10, 20) | 17 (10, 60) | 17 (5, 30) | 15 (10, 20) | 15 (10, 30) | 17 (5, 30) | 20 (15, 30) |
Data are mean ± SD, n (%), or median (25th, 75th percentile). One participant completed only one of two scheduled dosing visits: a 10-year-old who withdrew from the study after the first dosing visit of 3 mg intranasal glucagon. Cmax, peak central laboratory glucagon concentration; IM, intramuscular; IN, intranasal.
aMinimum central laboratory glucose value measured within 10 min after glucagon administration;
bmaximum glucose after administration of glucagon;
cthe one participant who failed to achieve a ≥25 mg/dL rise in glucose blew his nose immediately after 2 mg intranasal dose administration and had a peak glucagon of only 324 pg/mL;
dexcludes the one participant who blew his nose and did not experience a ≥25 mg/dL rise in glucose.