Table 2.
Outcome | Baseline (Mean ± SD) |
Δ Baseline to Month 6 (LS Mean ± SE) |
Δ from Control (LS Mean [95% CI]) |
---|---|---|---|
Insulin, pmol/L | |||
Control | 99.2±60.5 | −7.36±9.41 | — |
Low-Dose | 101.8±40.5 | −28.02±8.35a | −20.66 [−45.32, 3.99] |
High-Dose | 135.1±87.1 | −20.70±9.35a | −13.34 [−39.33, 12.6] |
Test for trend | Linear, P=0.170; Nonlinear, P=0.042 | ||
Glucose, mmol/L | |||
Control | 5.3±1.0 | 0.01±0.16 | — |
Low-Dose | 5.3±0.8 | −0.39±0.15a | −0.39 [−0.83, 0.05] |
High-Dose | 6.1±2.3 | −0.09±0.17 | −0.09 [−0.56, 0.38] |
Test for trend | Linear, P=0.931; Nonlinear, P=0.004 | ||
Insulin Resistance (HOMA) | |||
Control | 2.2±1.3 | −0.11±0.20 | — |
Low-Dose | 2.2±0.9 | −0.63±0.17a | −0.52 [−1.03, −0.01]b |
High-Dose | 2.9±2.0 | −0.43±0.19a | −0.32 [−0.86, 0.22] |
Test for trend | Linear, P=0.125; Nonlinear, P=0.012 | ||
IGF-1, nmol/L | |||
Control | 58.0±15.9 | −4.57±3.23 | — |
Low-Dose | 59.8±13.2 | −0.94±3.21 | 3.63 [−5.29, 12.56] |
High-Dose | 64.7±17.5 | 1.62±3.57 | 6.19 [−3.25, 15.62] |
Test for trend | Linear, P=0.054; Nonlinear, P=0.850 | ||
IGFBP-3, nmol/L | |||
Control | 1765.1±446.8 | −103.71±69.15 | — |
Low-Dose | 1925.7±449.5 | −30.01±68.04 | 73.69 [−116.96, 264.34] |
High-Dose | 2290.0±748.2 | −154.28±71.97a | −50.58 [−246.83, 145.68] |
Test for trend | Linear, P=0.685; Nonlinear, P=0.093 | ||
C-Peptide, nmol/L | |||
Control | 0.64±0.4 | 0.007±0.033 | — |
Low-Dose | 0.58±0.3 | −0.003±0.032 | −0.010 [−0.10, 0.08] |
High-Dose | 0.75±0.3 | −0.013±0.035 | −0.020 [−0.11, 0.07] |
Test for trend | Linear, P=0.701; Nonlinear, P=0.934 | ||
Fructosamine, mmol/L | |||
Control | 201.4±20.5 | 2.60±16.82 | — |
Low-Dose | 183.0±51.2 | 22.91±15.84 | 20.31 [−24.98, 65.60] |
High-Dose | 204.1±28.6 | −12.65±16.96 | −15.26 [−62.08, 31.57] |
Test for trend | Linear, P=0.380; Nonlinear, P=0.382 |
SD, standard deviation; LS Mean, least squares mean; SE, standard error; CI, confidence interval; HOMA, homeostatic model assessment.
Signifcantly different from baseline (within-group), P≤0.05.
Significantly different from control, P≤0.05.
Changes in outcomes are estimated using a linear mixed-effects regression model that adjusted for the baseline value of the dependent variable and cancer stage (randomization stratification factor).