Table 2—

Incidence of severe hypoglycemia and treatment-emergent adverse events with an incidence ≥10% and the incidence in one of the pramlintide groups at least double that of the placebo group (ITT population)

Placebo TIDPramlintide 90 μg BIDPramlintide 120 μg BID
Severe hypoglycemia*
 0–52 weeks0.3 ± 0.050.1 ± 0.030.3 ± 0.05
 0–4 weeks0.3 ± 0.200.1 ± 0.080.9 ± 0.30
 4–26 weeks0.3 ± 0.070.2 ± 0.060.4 ± 0.09
 26–52 weeks0.2 ± 0.060.0 ± 0.020.1 ± 0.05
Nausea (%)
 0–52 weeks14 (1)31 (4)30 (2)
 0–4 weeks3 (0)18 (2)16 (2)
 4–26 weeks5 (1)5 (2)8 (0)
 26–52 weeks4 (0)3 (0)3 (0)
Headache (%)8 (0)15 (1)17 (1)
  • *

    * Event rate per patient year (total number of events for all patients in a given treatment regimen/total number of patient years of observation for all patients in that treatment regimen). Values are mean ± standard deviation.

  • Non-severe (severe) as defined in research design and methods.