Skip to Main Content
Table 1—

Demographic and baseline characteristics (all randomized subjects)

CharacteristicMetforminPlacebo
Sex 42   40   
 Male 12 (28.6) 13 (32.5) 
 Female 30 (71.4) 27 (67.5) 
Age (years)   
 Mean 13.9 ± 1.8 13.6 ± 1.8 
 Median 14   14   
 Range 10–16 10–17* 
Age (years)   
 8 to <10  0    0   
 10 to <12 5 (11.9) 7 (17.5) 
 12 to <14 9 (21.4) 12 (30.0) 
 14 to <16 18 (42.9) 14 (35.0) 
 ≥16 10 (23.8) 7 (17.5) 
Race   
 White 17 (40.5) 13 (32.5) 
 Black 11 (26.2) 13 (32.5) 
 Asian/Pacific Islander 3 (7.1) 1 (2.5) 
 Hispanic/Latino 9 (21.4) 9 (22.5) 
 Other 2 (4.8) 4 (10.0) 
Weight (kg)   
 Mean 92.8 ± 31.8 90.3 ± 38.1 
 Median 91.0 87.9 
 Range 43.0–160.5 32.0–196.4 
BMI   
 Mean 34.2 ± 10.6 33.9 ± 12.7 
 Median 33.2 32.0 
 Range 19.2–58.4 18.1–82.8 
BMI (kg/m2  
 <75th Percentile for age 6 (14.3) 8 (20.0) 
 ≥75th Percentile for age 36 (85.7) 32 (80.0) 
FPG (mmol/l)   
 Mean 9.2 ± 2.8 11.0 ± 3.3  
 <7.0 10 (23.8)§ 4 (10.0)§ 
 7.0 to <8.9 12 (28.6) 7 (17.5) 
 8.9 to <11.1 11 (26.2) 9 (22.5) 
 11.1 to <13.3 2 (4.8) 11 (27.5) 
 ≥13.3 7 (16.7) 9 (22.5) 
HbA1c (%)   
 Mean 8.3 ± 1.3 9.0 ± 1.4 
 <7.0 5 (11.9)§ 1 (2.5) 
 7.0 to <8.0 14 (33.3) 7 (17.5) 
 8.0 to <9.0 12 (28.6) 17 (42.5) 
 9.0 to <10.0 5 (11.9) 7 (17.5) 
 ≥10.0 6 (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) 
CharacteristicMetforminPlacebo
Sex 42   40   
 Male 12 (28.6) 13 (32.5) 
 Female 30 (71.4) 27 (67.5) 
Age (years)   
 Mean 13.9 ± 1.8 13.6 ± 1.8 
 Median 14   14   
 Range 10–16 10–17* 
Age (years)   
 8 to <10  0    0   
 10 to <12 5 (11.9) 7 (17.5) 
 12 to <14 9 (21.4) 12 (30.0) 
 14 to <16 18 (42.9) 14 (35.0) 
 ≥16 10 (23.8) 7 (17.5) 
Race   
 White 17 (40.5) 13 (32.5) 
 Black 11 (26.2) 13 (32.5) 
 Asian/Pacific Islander 3 (7.1) 1 (2.5) 
 Hispanic/Latino 9 (21.4) 9 (22.5) 
 Other 2 (4.8) 4 (10.0) 
Weight (kg)   
 Mean 92.8 ± 31.8 90.3 ± 38.1 
 Median 91.0 87.9 
 Range 43.0–160.5 32.0–196.4 
BMI   
 Mean 34.2 ± 10.6 33.9 ± 12.7 
 Median 33.2 32.0 
 Range 19.2–58.4 18.1–82.8 
BMI (kg/m2  
 <75th Percentile for age 6 (14.3) 8 (20.0) 
 ≥75th Percentile for age 36 (85.7) 32 (80.0) 
FPG (mmol/l)   
 Mean 9.2 ± 2.8 11.0 ± 3.3  
 <7.0 10 (23.8)§ 4 (10.0)§ 
 7.0 to <8.9 12 (28.6) 7 (17.5) 
 8.9 to <11.1 11 (26.2) 9 (22.5) 
 11.1 to <13.3 2 (4.8) 11 (27.5) 
 ≥13.3 7 (16.7) 9 (22.5) 
HbA1c (%)   
 Mean 8.3 ± 1.3 9.0 ± 1.4 
 <7.0 5 (11.9)§ 1 (2.5) 
 7.0 to <8.0 14 (33.3) 7 (17.5) 
 8.0 to <9.0 12 (28.6) 17 (42.5) 
 9.0 to <10.0 5 (11.9) 7 (17.5) 
 ≥10.0 6 (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.

Close Modal

or Create an Account

Close Modal
Close Modal