Table 1—

Characteristics and demographics at visit 3 of all randomly assigned subjects beginning active therapy

PioglitazoneRosiglitazoneP value
n369366
Sex0.824
    Male199 (53.9)201 (54.9)
    Female170 (46.1)165 (45.1)
Age (years)55.9 ± 10.556.3 ± 11.30.572
Race0.842
    White239 (64.8)219 (59.8)
    Hispanic105 (28.5)118 (32.2)
    Asian10 (2.7)12 (3.3)
    African9 (2.4)10 (2.7)
    Other6 (1.6)7 (1.9)
Duration of diabetes (years)3.9 ± 4.44.0 ± 4.60.847
Body weight (kg)93.7 ± 20.692.5 ± 21.00.450
BMI (kg/m2)33.7 ± 12.932.6 ± 6.60.122
A1C (%)7.6 ± 1.27.5 ± 1.20.230
Fasting plasma glucose (mg/dl)180.5 ± 59.7177.3 ± 57.40.459
Previous treatment*280 (75.9)274 (74.9)0.797
    Metformin97/212 (45.8)92/206 (44.7)
    Insulin secretagogues97/212 (45.8)95/206 (46.1)
    Thiazolidinediones18/212 (8.5)19/206 (9.2)
Fasting lipid profile
    Total triglycerides (mg/dl)258.5 ± 159.4239.5 ± 132.60.079
    Total cholesterol (mg/dl)193.4 ± 31.3193.7 ± 33.70.882
    LDL cholesterol (mg/dl)106.9 ± 25.4109.0 ± 25.90.260
    HDL cholesterol (mg/dl)38.8 ± 10.039.7 ± 10.30.211
Apolipoprotein B (g/l)1.05 ± 0.201.04 ± 0.200.781
Fasting free fatty acid (mEq/l)0.64 ± 0.280.62 ± 0.290.579
Fasting insulin (μU/ml)19.7 ± 19.417.8 ± 14.30.132
Fasting C-peptide (ng/ml)3.9 ± 1.73.6 ± 1.60.043
HOMA
    Insulin resistance8.2 ± 6.47.7 ± 7.20.386
    β-Cell function83.6 ± 125.271.1 ± 69.70.095
Systolic blood pressure (mmHg)128.4 ± 15.9129.1 ± 16.40.584
Diastolic blood pressure (mmHg)78.7 ± 9.378.5 ± 8.90.765
Preexisting CVD or previous MI31 (8.4)24 (6.6)0.401
Aspartate aminotransferase (units/l)22.0 ± 7.121.7 ± 7.50.547
Alanine aminotransferase (units/l)27.0 ± 10.725.6 ± 10.90.063
Creatine phosphokinase (units/l)108.0 ± 85.1109.6 ± 77.70.790
Plasminogen activator inhibitor 1 (ng/ml)64.2 ± 43.459.6 ± 40.40.143
C-reactive protein (mg/l)7.0 ± 10.16.6 ± 7.70.580
  • Data are n (%) or means ± SD.

  • *

    * Totals of 280 (pioglitazone) and 274 (rosiglitazone) patients reported previous antidiabetes therapy, but only 212 (pioglitazone) and 206 (rosiglitazone) patients reported the class of previous antidiabetes therapy.

  • Includes short-acting secretagogues repaglinide and nateglinide. HOMA, homeostasis model assessment; MI, myocardial infarction.