Table 1—

Demographic characteristics (randomized population)

Colesevelam HClPlaceboP
n230231
Age (years)56.6 ± 10.357.0 ± 10.30.670
Sex0.575
    Male128 (55.7)122 (52.8)
    Female102 (44.3)109 (47.2)
Race/ethnicity0.438
    Caucasian135 (58.7)128 (55.4)
    Hispanic66 (28.7)59 (25.5)
    African-American23 (10.0)34 (14.7)
    Asian4 (1.7)7 (3.0)
    Other2 (0.9)3 (1.3)
Weight (kg)95.0 ± 22.692.5 ± 20.20.197
BMI (kg/m2)33.1 ± 5.9532.5 ± 5.640.225
A1C (%)8.2 ± 0.688.3 ± 0.720.054
FPG (mg/dl)176.6 ± 46.5181.0 ± 50.40.323
Concomitant antidiabetes medication status
    Sulfonylurea monotherapy75 (32.6)81 (35.1)
        Glibenclamide39 (52.0)44 (54.3)
        Glipizide24 (32.0)25 (30.9)
        Glimepiride10 (13.3)12 (14.8)
        Tolbutamide1 (1.3)0
        Gliclazide1 (1.3)0
    Sulfonylurea combination therapy154 (67.0)150 (64.9)
Concomitant antidiabetes medications in the sulfonylurea combination therapy group*
    Sulfonamides, urea derivatives120 (77.9)122 (81.3)
        Glipizide62 (40.3)50 (33.3)
        Glibenclamide37 (24.0)50 (33.3)
        Glimepiride21 (13.6)21 (14.0)
        Tolazamide1 (0.6)2 (1.3)
    Biguanides104 (67.5)105 (70.0)
    Thiazolidinediones40 (26.0)40 (26.7)
    Biguanide/sulfonamide fixed-dose combinations33 (21.4)27 (18.0)
    α-glucosidase inhibitors01 (0.7)
    Other antidiabetes agents13 (8.4)10 (6.7)
  • Data are means ± SD and n (%) unless otherwise indicated.

  • * Some subjects took more than one oral antidiabetes agent in combination with background sulfonylurea therapy, and thus the total number of concomitant oral antidiabetes agents in the columns exceed the n values in the colesevelam HCl and placebo columns.

  • Other antidiabetes agents includes fixed-dose rosiglitazone/metformin, fixed-dose glipizide/metformin, nateglinide, and repaglinide.