Table 1—

Baseline demographics, background characteristics, and disposition of randomly assigned patients

Vildagliptin, 50 mg q.d.Placebo
n9089
Age57.1 ± 10.759.8 ± 11.5
    <65 years62 (68.9)51 (57.3)
    ≥65 years28 (31.1)38 (42.7)
Male sex43 (47.8)38 (42.7)
Race
    Caucasian81 (90.0)80 (89.9)
    Hispanic or Latino4 (4.4)7 (7.9)
    Black3 (3.3)1 (1.1)
    All other2 (2.2)1 (1.1)
BMI31.7 ± 4.830.9 ± 5.3
    BMI <30 kg/m239 (43.3)45 (50.6)
    BMI ≥30 kg/m251 (56.7)44 (49.4)
    BMI ≥35 kg/m222 (22.4)19 (21.3)
A1C (%)5.9 ± 0.55.9 ± 0.4
FPG (mmol/l)6.2 ± 0.76.1 ± 0.7
2-h glucose (mmol/l) (OGTT)9.1 ± 0.99.2 ± 0.9
Pre-diabetic status
    Isolated IGT15 (16.7)18 (20.2)
    IGT plus IFG75 (83.3)71 (79.8)
Completed84 (93.3)84 (94.4)
Discontinued6 (6.7)5 (5.6)
    Adverse event3 (3.3)2 (2.2)
    Protocol violation1 (1.1)2 (2.2)
    Withdrew consent1 (1.1)1 (1.1)
    Lost to follow-up1 (1.1)0
  • Data are means ± SD or n (%)