Table 1—

Characteristics of enrolled population and subject disposition

BIAsp 70/30Glargine
Subjects randomized (n)117116
Age (years)52.6 ± 10.652.3 ± 9.8
Sex (%) (M/F)53/4756/44
Ethnicity (%) (C/B/H/A/O)*55/15/27/2/252/17/26/4/1
Weight (kg)90.6 ± 18.889.9 ± 19.0
BMI (kg/m2)31.5 ± 5.531.4 ± 5.3
Prior TZD use (yes/no)38 (32)/79 (68)38 (33)/78 (67)
Diabetes duration (years)9.5 ± 5.98.9 ± 4.8
HbA1c (%) (all subjects)9.7 ± 1.59.8 ± 1.4
    Subjects with HbA1c >8.5% at baseline (n)10.2 ± 1.3 (89)10.1 ± 1.3 (99)
    Subjects with A1C ≤8.5% at baseline (n)8.0 ± 0.4 (28)8.1 ± 0.3 (17)
    Subjects on prestudy TZD (n)9.3 ± 1.5 (38)9.7 ± 1.1 (38)
    Subjects not on prestudy TZD (n)9.9 ± 1.5 (79)9.9 ± 1.6 (78)
Completed study100 (85)109 (94)
Discontinuation from study17 (15)7 (6)
    For adverse event4 (3)1 (1)
    For noncompliance5 (4)3 (3)
    For ineffective therapy1 (1)0
    For “other”7 (6)3 (3)
  • Data are means ± SD or n (%) unless otherwise indicated.

  • *

    * A, Asian; B, black; C, Caucasian; H, Hispanic; O, other.

  • Baseline HbA1c values for subjects on a prestudy TZD are not significantly different (P = 0.1441).

  • Adverse event withdrawals in the BIAsp 70/30 group were unrelated to treatment: stroke, adenocarcinoma, chest pain, and gastrointestinal bleeding. Adverse event withdrawal in the glargine group had a possible study drug relationship: injection site stinging. Reasons for “other” included lost to follow-up, failure to return, and subject withdrawing consent.