Hypoglycemia rates and incidence
Rates are geometric least squares means } SE (documented symptomatic and nocturnal) or means } SD (severe).
NOTE: During this trial, hypoglycemia was categorized as documented symptomatic, nocturnal, or severe hypoglycemia.
Documented symptomatic hypoglycemia was defined as signs or symptoms associated with hypoglycemia and a plasma glucose ≤70 mg/dL or <50 mg/dL. Nocturnal hypoglycemia was defined as documented symptomatic hypoglycemia occurring between bedtime and waking. By definition, severe hypoglycemia required assistance from another person for treatment and was accompanied by neurologic/cognitive impairment. Incidence is reported as the number of patients with at least one hypoglycemic episode.
All hypoglycemic analyses were performed using the full analysis set defined as all randomized patients receiving at least one dose of study drug.