Table 2.
Differences between dosing-interval groups for IGF1 levels (% ULN) in patients with normalized levels at week 48 (end of study; secondary endpoints). Data are from the modified intention-to-treat population.
| 4-week DI (n=13) | 6-week EDI (n=70) | 8-week EDI (n=26) | Between-group differences | ||||
|---|---|---|---|---|---|---|---|
| 4-week DI vs 6-week EDI | 6-week EDI vs 8-week EDI | 4-week DI vs 8-week EDI | 4-week DI vs 6-+8-week EDI | ||||
| Baseline a , mean (s.d.) | (n=12) | (n=67) | (n=25) | ||||
| 98.7 (14.6) | 67.8 (30.3) | 51.3 (24.7) | 30.9 (13.1–48.8)‡ | 16.5 (3.0–29.9)* | 47.4 (31.7–63.1)‡ | 35.1 (18.1–52.7)‡ | |
| Change from | (n=12) | (n=67) | (n=25) | ||||
| baseline to week 48 b , adjusted mean (s.e.m.) | 24.8 (5.3) | 6.1 (2.1) | −17.9 (3.5) | 18.7 (7.5–29.9)† | 24.0 (15.8–32.1)‡ | 42.7 (29.5–55.8)‡ | N/A |
*P<0.05, † P<0.01, ‡ P<0.001. DI, dosing interval; EDI, extended dosing interval; IGF1, insulin-like growth-factor 1; NA, not applicable; ULN, upper limit of normal.
a
Between group differences are presented as mean (95% CI) using student's t-test (two-sided).
b
Between group differences are presented as adjusted mean (95% CI) of the analysis of covariance with injection interval group as main factor and baseline level as covariate.