ORLANDO, Fla., June 28 /PRNewswire-FirstCall/ -- Today Novo Nordisk announced results of its STEPwise™ trial, which identified a method of intensifying insulin treatment with NovoLog® (insulin aspart [rDNA origin] injection). The study, presented at the American Diabetes Association (ADA) 2010 Scientific Sessions, demonstrated a reduction of A1c levels in type 2 diabetes patients when a dose of NovoLog® was introduced at meals, using two approaches that start with the largest meal of the day, in addition to once-daily Levemir® (insulin detemir [rDNA origin] injection) plus oral medications.
The 48-week open-label, randomized, multinational trial compared two step-wise methods of gradually intensifying treatment with NovoLog® in patients with type 2 diabetes taking once-daily Levemir® plus oral medication:
- "SimpleSTEP" (fewer blood sugar measurements): Patients were given their first routine daily dose of NovoLog® at their largest meal and additional doses of NovoLog® were added in sequence based on their blood sugar levels before the meal
- "ExtraSTEP" (more frequent blood sugar measurements): Patients were given their first routine daily dose of NovoLog® at the meal with the largest increase in blood sugar before and after the meal, and adjusted the dose amount based on the amount of rise in blood sugar before and after the meal
After 12 weeks, patients in either arm who had an A1c of greater than 7% received a second dose of NovoLog® at another meal. At 24 weeks, patients were held to the same A1c targets and given a dose of NovoLog® at a third meal if A1c was still greater than 7%. After 48 weeks, investigators concluded that the step-wise addition of NovoLog® to Levemir® plus oral medication, as