Placebo (n=16) | Teduglutide 0.10 mg/kg/day (n=32) | p1 Value | Teduglutide 0.05 mg/kg/day (n=35) | p2 Value | |
FM, kg | |||||
Baseline | n=16 | n=31 | 0.80 | n=34 | 0.12 |
15.95±5.50 | 15.46±6.55 | 13.22±5.78 | |||
Week 24 | n=14 | n=29 | 0.66 | n=28 | 0.07 |
16.50±4.94 | 15.64±6.70 | 13.10±5.93 | |||
Absolute change | n=14 | n=29 | 0.19 | n=27 | 0.86 |
−0.63±1.88 | 0.38±1.98 | −0.34±2.38 | |||
Relative change (%) | n=14 | n=29 | 0.21 | n=27 | 1.00 |
−3.8±11.0 | 4.6±16.5 | −1.6±22.2 | |||
LBM, kg | |||||
Baseline | n=16 | n=31 | 0.60 | n=34 | 0.89 |
42.42±7.82 | 41.19±7.50 | 42.77±8.28 | |||
Week 24 | n=14 | n=29 | 0.55 | n=28 | 0.37 |
41.52±8.64 | 43.12±7.87 | 43.97±8.19 | |||
Absolute change | n=14 | n=29 | 0.004 | n=27 | 0.06 |
−0.52±1.18 | 1.53±2.37 | 0.82±2.17 | |||
Relative change (%) | n=14 | n=29 | 0.0033 | n=27 | 0.051 |
−1.4±3.0 | 3.8±5.9 | 2.0±5.2 | |||
TBBMC, kg | |||||
Baseline | n=16 | n=31 | 0.003 | n=34 | 0.03 |
2.42±0.47 | 2.00±0.41 | 2.10±0.47 | |||
Week 24 | n=15 | n=29 | 0.017 | n=28 | 0.079 |
2.39±0.50 | 2.04±0.42 | 2.14±0.40 | |||
Absolute change | n=15 | n=29 | 0.046 | n=27 | 0.06 |
−0.016±0.05 | 0.010±0.045 | 0.009±0.048 | |||
Relative change (%) | n=15 | n=29 | 0.045 | n=27 | 0.09 |
−0.8±2.1 | 0.6±2.4 | 0.4±2.4 |
Values shown are mean±SD.
p1 and p2 values for treatment differences from a general linear model (GLM) method with dependent variable changes from baseline in the corresponding variables, independent variable treatment and corresponding variables at baseline as covariates.
FM, fat mass; LBM, lean body mass; TBBMC, total body bone mineral content.