In the same study, children as young as 2 years of age with type 1 diabetes who received Levemir® had comparable hypoglycemic episodes vs children who received NPH insulin.2,b
Pediatric efficacy and safety for Levemir®
Mean A1C values, measured over the 52-week period, for children and adolescents taking Levemir® and NPH insulin2
aFrom an ANCOVA model adjusted for baseline value, country, pubertal status at baseline, and age (stratification factor).
bNon-severe hypoglycemia=asymptomatic events with PG <65 mg/dL as well as symptomatic events that were self-treated or treated by taking oral therapy provided by the caregiver. Severe hypoglycemia = event with semi-consciousness, unconsciousness, coma and/or convulsions in a child who could not assist in treatment and who may have required glucagon or IV glucose.
In a 52-week, randomized, controlled, open-label study, 347 children and adolescents with type 1 diabetes were stratified according to age (2 to 5 years, n=82; 6 to 16 years, n=265) at randomization.
- This study evaluated the safety and efficacy of Levemir® and NPH insulin as part of a basal-bolus regimen that included NovoLog® (insulin aspart injection) 100 U/mL before each meal
- Patients were randomized to receive either Levemir® (n=177) or NPH insulin (n=170) once or twice daily according to their pretrial basal insulin dose regimen
- Patients in the NPH insulin group had no change in FPG (baseline=141 mg/dL)
- This study had comparable rates of hypoglycemia between Levemir® and NPH insulin