Table 1—

Demographic and baseline characteristics (all randomized subjects)

CharacteristicMetforminPlacebo
Sex42  40  
 Male12 (28.6)13 (32.5)
 Female30 (71.4)27 (67.5)
Age (years)
 Mean13.9 ± 1.813.6 ± 1.8
 Median14  14  
 Range10–1610–17*
Age (years)
 8 to <10 0   0  
 10 to <125 (11.9)7 (17.5)
 12 to <149 (21.4)12 (30.0)
 14 to <1618 (42.9)14 (35.0)
 ≥1610 (23.8)7 (17.5)
Race
 White17 (40.5)13 (32.5)
 Black11 (26.2)13 (32.5)
 Asian/Pacific Islander3 (7.1)1 (2.5)
 Hispanic/Latino9 (21.4)9 (22.5)
 Other2 (4.8)4 (10.0)
Weight (kg)
 Mean92.8 ± 31.890.3 ± 38.1
 Median91.087.9
 Range43.0–160.532.0–196.4
BMI
 Mean34.2 ± 10.633.9 ± 12.7
 Median33.232.0
 Range19.2–58.418.1–82.8
BMI (kg/m2)
 <75th Percentile for age6 (14.3)8 (20.0)
 ≥75th Percentile for age36 (85.7)32 (80.0)
FPG (mmol/l)
 Mean9.2 ± 2.811.0 ± 3.3 
 <7.010 (23.8)§4 (10.0)§
 7.0 to <8.912 (28.6)7 (17.5)
 8.9 to <11.111 (26.2)9 (22.5)
 11.1 to <13.32 (4.8)11 (27.5)
 ≥13.37 (16.7)9 (22.5)
HbA1c (%)
 Mean8.3 ± 1.39.0 ± 1.4
 <7.05 (11.9)§1 (2.5)
 7.0 to <8.014 (33.3)7 (17.5)
 8.0 to <9.012 (28.6)17 (42.5)
 9.0 to <10.05 (11.9)7 (17.5)
 ≥10.06 (14.3)8 (20.0)
Stimulated C-peptide (nmol/l)2.4 (1.1)2.2 (1.1)
Total cholesterol (mmol/l)§4.5 (1.0)4.9 (1.0)
HDL cholesterol (mmol/l)§1.1 (0.3)1.1 (0.3)
LDL cholesterol (mmol/l)§2.6 (0.8)2.9 (0.7)
Triglycerides (mmol/l)1.7 (1.3)2.3 (2.2)
  • Data are n (%) or means ± SD, unless otherwise indicated.

  • *

    * One subject was 16 years of age at the time the informed consent was signed, but had a birthday between the signing date and the screening visit.

  • The FPG and HbA1c values provided were the values at the randomization visit (visit 2). The inclusion criteria had to be met only at screening (visit 1); consequently, at randomization some subjects had levels outside the range given in the inclusion criteria.

  • Number and percentage of subjects who fell in to each category.

  • §

    § To convert cholesterol levels from millimoles per liter to milligrams per deciliter, divide by 0.259. Data are rounded.

  • To convert triglyceride levels from millimoles per liter to milligrams per deciliter, divide by 0.0113.

  • One subject had a triglyceride level of 12.0 mmol/l, which contributed to the higher mean for the placebo group.