Table 1—

Patient disposition and baseline demographics

Total population
Placebo baseline A1C
Pramlintide baseline A1C
PlaceboPramlintide≤8.5%>8.5%≤8.5%>8.5%
Disposition (n)
    Randomized10710559486342
    Completed918751405235
    Withdrew161888117
    Reason for withdrawal
        Withdrawal of consent1295763
        Adverse event141031
        Investigator decision302100
        Protocol violation020011
        Lost to follow-up030012
Baseline demographics
    Intent-to-treat population (n)10610558486342
    Sex (male/female) (n)55/5148/5735/2320/2832/3116/26
    Race (Caucasian/other) (n)77/2977/2840/1837/1147/1630/12
    Age (years)55 ± 1055 ± 955 ± 1156 ± 956 ± 853 ± 9
    Weight (kg)103 ± 18103 ± 18105 ± 2099 ± 16104 ± 18102 ± 16
    BMI (kg/m2)35 ± 635 ± 535 ± 635 ± 635 ± 536 ± 4
    Diabetes duration (years)10 ± 611 ± 610 ± 611 ± 611 ± 611 ± 6
    A1C (%)8.5 ± 0.98.5 ± 0.97.7 ± 0.49.3 ± 0.67.9 ± 0.49.4 ± 0.7
    FPG (mg/dl)140 ± 54146 ± 52133 ± 57150 ± 50132 ± 45167 ± 56
    PPG increments (mg/dl)57 ± 2759 ± 2958 ± 2956 ± 2658 ± 2862 ± 32
    OA use (n)969254425933
    Sulfonylurea use (no/yes) (n)50/5654/5126/3224/2430/3324/18
    Daily insulin dose (units)54 ± 4248 ± 2557 ± 4351 ± 4244 ± 2255 ± 29
  • Data are means ± SD, unless otherwise indicated.