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 outlined in the study, can be equally effective, whether using a more intuitive approach (like SimpleSTEP) or one with more frequent, precise measurements of blood sugar levels (like ExtraSTEP), for intensifying therapy in patients with type 2 diabetes to lower A1c levels.
“A significant challenge for physicians treating patients with type 2 diabetes is figuring out how to introduce a meal-time insulin when basal insulin with or without oral medications is no longer enough to keep blood sugar levels stable,” said Luigi Meneghini, M.D., M.B.A., lead investigator in the STEPwise™ trial, Professor of Clinical Medicine at the University of Miami Miller School of Medicine. “With the SimpleSTEP and ExtraSTEP algorithms, we have identified an approach for how to gradually introduce and intensify doses of NovoLog® at mealtimes in patients who increasingly need glucose control as their diabetes progresses.”
More details of the study will be presented at the American Diabetes Association’s Scientific Sessions in Orlando, FL on Monday, June 28 during Poster Session III, 12:00-2:00 p.m. in the Orange County Convention Center, Hall C.
About the STEPwise Trial(1)
The trial involved 296 patients, at an average age of 58 and mean A1c of 8.8% on basal insulin and oral medications. The primary efficacy endpoint was HbA1c after 36 weeks of treatment. Treatment was given with Levemir® FlexPen® once daily in combination with NovoLog® FlexPen® one to three times daily, before meals, with the dose adjusted individually based on defined titration guidelines developed for the study.
- The mean observed HbA1c after 36 weeks of treatment was 7.7% in the ExtraSTEP treatment group and 7.5% in the SimpleSTEP treatment group.
- The mean (absolute) change in HbA1c was -1.3% in the ExtraSTEP treatment group and -1.1% in the SimpleSTEP treatment group.