Table 1—

Patients studied and baseline characteristics of the primary ITT population

50 mg vildagliptin daily100 mg vildagliptin dailyPlacebo
Analysis populations
    Randomized177185182
    Safety177183181
    Primary ITT143143130
    ITT174175171
    Meal test participants555854
Primary ITT population
    Age (years)54.3 ± 9.753.9 ± 9.554.5 ± 10.3
    Sex
        Male82 (57.3)88 (61.5)69 (53.1)
        Female61 (42.7)55 (38.5)61 (46.9)
    Race
        Caucasian106 (74.1)106 (74.1)95 (73.1)
        Hispanic or Latino24 (16.8)19 (13.3)24 (18.5)
        Black9 (6.3)13 (9.1)9 (6.9)
        All other4 (2.8)5 (3.5)2 (1.5)
    BMI (kg/m2)32.1 ± 5.332.9 ± 5.033.2 ± 6.1
    A1C (%)8.4 ± 0.98.4 ± 1.08.3 ± 0.9
    FPG (mmol/l)9.7 ± 2.29.9 ± 2.610.1 ± 2.4
    Disease duration (years)6.8 ± 5.55.8 ± 4.76.2 ± 5.3
    Duration of metformin (months)17.8 ± 23.217.9 ± 23.015.9 ± 16.7
    Metformin dose (mg/day)2,126 ± 2982,099 ± 3282,102 ± 320
  • Data are n, mean ± SD, or n (%).