Table 1

End of the trial measures by treatment group

Active pramlintidePlacebo pramlintideUnadjusted effect size (η, SDU)Adjusted effect size (β, SDU)
n129134
Clinical outcomes
    Log number of hypoglycemic events3.67 ± 1.093.40 ± 1.040.12*, 0.250.15*, 0.28
    Severe hypoglycemic event27.1%13.4%0.13*, 0.280.17, 0.34
    Maximal pramlintide dose72.1%93.3%0.28, 0.55−0.29, 0.58
    Change in insulin requirement (units/day)0.59 ± 74.044.76 ± 34.340.04, 0.070.04, 0.07
    Change in weight (kg)−1.60 ± 3.801.28 ± 2.940.39, 0.79−0.40, 0.81
    Change in A1C (%)−0.38 ± 0.86−0.45 ± 0.850.04, 0.080.03, 0.06
    Change in PPG (mg/dl)−38.27 ± 39.18−7.40 ± 38.250.37, 0.74−0.35, 0.71
Patient reported outcomes
    Glucose control4.18 ± 1.443.15 ± 1.650.32, 0.630.34, 0.67
    Flexible eating3.42 ± 1.532.89 ± 1.630.17, 0.330.20, 0.39
    Weight control3.70 ± 1.742.33 ± 1.410.40, 0.800.41, 0.83
    Appetite control4.00 ± 1.712.63 ± 1.530.39, 0.780.41, 0.82
    Hypoglycemia prevention2.84 ± 1.402.72 ± 1.410.04, 0.090.04, 0.09
    Absence of side effects4.71 ± 1.665.31 ± 1.220.20, 0.41−0.19, 0.39
    Treatment satisfaction3.79 ± 1.352.83 ± 1.430.33, 0.650.35, 0.69
    Treatment preference4.77 ± 1.494.22 ± 1.750.17, 0.330.17, 0.34
  • Data are means ± SD, unless otherwise indicated. Effect sizes for study outcomes were measured by ANOVA with the η-statistic (unadjusted) and ANCOVA with the β-statistic (adjusted for race, sex, age, duration of diabetes, multiple daily injections/continuous subcutaneous insulin infusion, and baseline values of insulin, weight, A1C, and PPG), as well as by the difference between treatment groups in SD units (SDU).

  • *P < 0.05;

  • P < 0.01;

  • P < 0.001.