Table 1—

Study disposition and demographic characteristics for the ITT population

DispositionDouble-blind study
Open-label extension
Placebo
Pramlintide
Placebo*
Pramlintide*
n%n%n%n%
ITT population237243111125
Withdrawals6929.16928.43834.23729.6
 Adverse event198.03112.81816.286.4
 Noncompliance135.583.3
 Protocol violation62.510.40054.0
 Withdrawal of consent145.9124.91513.51814.4
 Other177.2177.054.564.8
Evaluable population16870.917471.67365.88870.4
Demographic Characteristics at Baseline
 Sex: male/female (%)55/4555/4556/4459/41
 Race: Caucasian/other (%)92/896/595/697/3
 Age (years)40.4 ± 12.140.3 ± 11.644.7 ± 11.742.7 ± 10.8
 Weight (kg)75.6 ± 13.375.0 ± 13.877.1 ± 13.776.0 ± 13.9
 BMI (kg/m2)25.8 ± 3.525.2 ± 3.326.3 ± 3.425.4 ± 3.3
 HbAlc (%)8.9 ± 1.58.7 ± 1.38.7 ± 1.38.3 ± 1.4
 Duration of diabetes (years)17.1 ± 10.516.5 ± 10.0
  • Data are means ± SD unless otherwise indicated.

  • *

    * Group to which patients were randomized during the initial double-blind study;

  • percentages do not add up to 100 due to rounding.