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.
Select Safety Information for Humulin R U-500
• Dosing Errors in the Vial Presentation, continued:
- Instruct patients to always check the insulin label before each injection.
- Use only a U-500 insulin syringe with Humulin R U-500 to avoid administration errors. Do not use any other type of syringe to administer Humulin R U-500. Adhere to administration instructions.
- Instruct the patient to inform hospital or emergency department staff of the dose of Humulin R U-500 prescribed.