Table 1.
12:12 Schedule |
14:10 Schedule |
LS mean difference | |
---|---|---|---|
Completers population | (n = 30) | (n = 30) | |
Baseline body weight (kg) | 121.3 ± 19.1 | 124.4 ± 20.5 | – |
95% CI | (114.3, 128.4) | (116.9, 132.0) | |
Week 8 body weight (kg) | 112.6 ± 18.1 | 113.8 ± 18.9 | – |
95% CI | (105.9, 119.3) | (106.8, 120.8) | |
Week 8 change in body weight (kg)a | −8.9 ± 4.2 | −10.7 ± 4.1 | 1.9 ± 4.5 |
95% CI | (−10.4, −7.3) | (−12.3, −9.2) | (0.2, 3.5) |
P value | <0.0001 | <0.0001 | 0.025 |
Week 8 change in body weight (kg)b | −5.4 ± 2.5 | −6.8 ± 3.0 | 1.5 ± 3.6 |
95% CI | (−6.3, −4.5) | (−7.9, −5.7) | (0.1, 2.8) |
P value | <0.0001 | <0.0001 | 0.032 |
Week 8 change in body weight (%)a | −7.1 ± 3.4 | −8.5 ± 3.0 | 1.4 ± 3.5 |
95% CI | (−8.3, −5.8) | (−9.6, −7.4) | (0.2, 2.7) |
P value | <0.0001 | <0.0001 | 0.027 |
Week 8 change in body weight (%)b | −5.0 ± 1.9 | −6.0 ± 1.8 | 1.0 ± 2.4 |
95% CI | (−5.7, −4.3) | (−6.7, −5.4) | (0.2, 1.9) |
P value | <0.0001 | <0.0001 | 0.020 |
Baseline FBG (mg/dl) | 101.5 ± 19.7 | 102.2 ± 23.6 | – |
95% CI | (94.3, 108.8) | (93.6, 110.9) | |
Week 8 FBG (mg/dl) 95% CI | 98.9 ± 14.4 (93.6, 104.2) | 95.2 ± 12.9 (90.4, 100.0) | – |
Week 8 change in FBG (mg/dl)a | −3.1 ± 18.5 | −7.6 ± 20.3 | 4.5 ± 21.3 |
95% CI | (−10.0, 3.7) | (−15.1, −0.1) | (−3.3, 12.3) |
P value | 0.36 | 0.047 | 0.23 |
Week 8 change in FBG (mg/dl)b | −9.6 ± 13.1 | −11.0 ± 16.6 | 1.5 ± 17.6 |
95% CI | (−14.3, −4.8) | (−17.1, −5.0) | (−5, 7.9) |
P value | <0.0001 | <0.0001 | 0.65 |
FBG ≥ 100 mg/dl at baseline (Completers) | n = 12 | n = 12 | |
Baseline FBG (mg/dl) | 113.6 ± 8.7 | 117.3 ± 21.8 | – |
95% CI | (108.1, 119.1) | (103.5, 131.0) | |
Week 8 FBG (mg/dl) | 101.7 ± 12.7 | 99.1 ± 13.5 | – |
95% CI | (93.8, 109.6) | (90.7, 107.6) | |
Week 8 change (mg/dl)a | −11.2 ± 15.8 | −17.6 ± 19.3 | 6.4 ± 22.4 |
95% CI | (−21.0, −1.4) | (−29.8, −5.5) | (−7.1, 20.0) |
P value | 0.029 | 0.008 | 0.33 |
Data are LS mean ± SD.
FBG fasting blood glucose.
aANOVA of the change from baseline to Week 8.
bANOVA of the change from baseline using repeated measures method that included all postbaseline measurements.