This model predicts that the liraglutide dose regimen used in adults will result in the same range of exposures in the pediatric population (10–17 years) with type 2 diabetes (T2D). |
This pharmacokinetic analysis of liraglutide in pediatric subjects with T2D could help broaden the range of treatment options for this population. |
1 Introduction
2 Methods
2.1 Data Sources Used to Populate the Pharmacokinetics Model
2.1.1 Pediatric Trial
2.1.2 Adult Trials
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 |