TABLE 3

Changes in laboratory variables at conclusion of the randomized phase

MetforminPlaceboDifferenceP
N5347
Serum insulin (μIU/mL)3.24 (−1.36 to 7.84)9.0 (3.84 to 14.15)−5.75 (−10.45 to −1.06)0.02
Plasma glucose (mg/dL)−0.88 (−3.81 to 2.05)3.47 (0.13 to 6.82)−4.35 (−7.51 to −1.19)0.007
HOMA-IR index*0.68 (−0.4 to 1.76)2.23 (1.02 to 3.43)−1.54 (−2.65 to −0.44)0.006
First-phase insulin secretion (μIU/mL)−7.26 (−31.4 to 16.88)−24.7 (−52.8 to 3.4)17.44 (−18.61 to 53.49)0.34
Clamp insulin sensitivity (mg/kg ⋅ min/μU/mL)0.53 (−0.77 to 1.83)−0.19 (−1.64 to 1.27)0.71 (−1.56 to 2.99)0.52
Total cholesterol (mg/dL)−9.05 (−16.64 to −1.47)−4.52 (−13.03 to 4.00)−4.54 (−12.53 to 3.46)0.27
HDL cholesterol (mg/dL)0.12 (−2.55 to 2.78)−0.27 (−3.28 to 2.73)0.39 (−2.49 to 3.28)0.79
LDL cholesterol (mg/dL)−6.57 (−14.09 to 0.95)−2.78 (−11.34 to 5.78)−3.79 (−12.02 to 4.43)0.37
LDL/HDL cholesterol ratio−0.15 (−0.43 to 0.12)−0.003 (−0.27 to 0.27)−0.12 (−0.40 to 0.15)0.21
Triglycerides (mg/dL)7.7 (−12.83 to 28.23)3.79 (−19.39 to 26.96)3.91 (−17.67 to 25.5)0.72
AST (U/L)−0.86 (−3.04 to 1.31)−0.89 (−3.36 to 1.57)0.03 (−2.27 to 2.33)0.98
ALT (U/L)3.01 (−0.71 to 6.73)2.63 (−1.65 to 6.92)0.38 (−3.72 to 4.48)0.86
High-sensitivity C-reactive protein (mg/dL)0.07 (−0.48 to 0.61)0.33 (−0.33 to 0.98)−0.26 (−0.95 to 0.43)0.45
Vitamin B12 (pg/mL)−57.1 (−170.3 to 56.1)173.8 (42.6 to 305.1)−230.9 (−356.9 to −105.0)<0.001
  • Estimated marginal means (95% CIs), adjusted for covariates including age, race, and sex, were reported from multiple imputation analyses. *HOMA-estimated insulin resistance.