Table 1.
Data sources for the population pharmacokinetic analysis (subject demographics and pharmacokinetic sampling details)
Trial 1 (NCT00943501) | Trial 2 (NCT00993304) | Trial 3 (NCT00873223) | |
---|---|---|---|
Population | Pediatric T2D | Adult T2D | Adult T2D |
No. of subjects | 13 | 12 | 32 |
Female [n (%)] | 8 (62) | 6 (50) | 9 (28) |
Age range, years | 10–17 | 54–73 | 33–68 |
Body weight, kg [median (range)] | 106 (57–214) | 83 (72–104) | 96 (58–140) |
Liraglutide doses with PK assessment | 0.3, 0.6, 1.2, 1.8a | 1.8 | 1.8 |
PK sampling times (h) |
−0.25, 2, 4, 8, 10, 11, 12, 14, 24b −0.25, 2, 5, 8, 10, 13b |
−0.25, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60 | 0, 2, 4, 6, 8, 9, 10, 11, 12, 14, 16, 18, 24 |
Mean total number of PK samples per subject during the trial (n) | 25c | 12 | 13 |
PK profiles per subject (n) | 4 | 1 | 1 |
Body weight was measured at randomization for Trial 1 and at sampling time for Trials 2 and 3
PK pharmacokinetic, T2D type 2 diabetes
aEvaluation of liraglutide pharmacokinetics at 0.9 mg and 1.5 mg doses was not specified in the trial protocol but represents protocol deviations due to mistakes in drug dosing (subject) and the timing of pharmacokinetic blood sampling (site)
bThe first four subjects had a 24-h blood sampling schedule. Following a protocol amendment which aimed to reduce the burden on the remaining subjects, the blood sampling period was changed from 24 to 13 h
cEach patient had a total of four pharmacokinetic sampling sessions (at the end of weeks 1, 2, 4, and 5)