NovoLog® has been studied in multiple approaches demonstrating insulin intensification. Results of the two studies, described below, show that NovoLog® helps lower A1C levels.1,2
NovoLog® helps lower A1C levels1,2
The FullSTEP® Study
A manageable, patient-titrated approach for glycemic control.
NovoLog® dosed in a stepwise approach was just as efficacious as full basal-bolus at study end.1
In the FullSTEP® study, patients uncontrolled on basal insulin with or without OADs were randomized to either a stepwise approach or a full basal-bolus dosing arm. In the stepwise arm, patients added NovoLog® to their basal insulin at the patient-perceived largest meal of the day. After 11 weeks and 22 weeks, additional doses of NovoLog® were added, if A1C was ≥ 7%, to the next largest patient-perceived largest meals. In the full basal-bolus arm, NovoLog® was added at all 3 main meals from the start. The study found that similar A1C and FPG results were demonstrated by study end when NovoLog® was initiated with 1 dose (stepwise arm) or 3 doses (full basal-bolus arm) (A1C. P=0.088; FPG. P=0.64)1
A1C reductions over 32 weeks with basal insulin plus NovoLog® in the stepwise approach versus the full basal-bolus approach
Rodbard et al (FullSTEP®), a randomized, open-label, multinational, non-inferiority, 32-week treat-to-target trial. Patients with type 2 diabetes inadequately controlled on basal insulin with or without OADs were randomized to either a stepwise arm or full basal-bolus arm. In the stepwise arm (n=201), NovoLog® (insulin aspart [rDNA origin] injection) was added to basal insulin at the patient-perceived largest meal initially. Additional doses were added to the next largest patient-perceived largest meal at weeks 11 and 22 if A1C ≥7%. In the full basal-bolus arm (n=200), NovoLog® was added at all 3 main meals from the start. Patients in both arms self-titrated NovoLog® daily based on the previous day's premeal or bedtime self-measured plasma glucose levels.
Adapted from Rodbard et al 20131
Mean total daily doses at the end of study in the stepwise arm
Even in patients with long-standing diabetes (>12 years), starting with only 1 dose of NovoLog® led to glycemic goal
A practical, patient-led approach to achieving glycemic control - 1 meal at a time1
The FullSTEP® study afforded patients a manageable approach to gain better control of type 2 diabetes. Starting with just 1 dose at their largest meal of the day to fit their daily routine, the FullSTEP® study enabled patients to take mealtime insulin initation 1 step at a time.a
Compared with full basal-bolus, the stepwise arm offered patients the potential of:1
- Fewer injections every day
- Fewer daily SMPG readings
Glucose monitoring is recommended for all patients with diabetes and management care plans should be individualized.
a Patients determined their largest meal of the day based on highest estimated carbohydrate intake.
b This was a 32-week study. In the stepwise arm (n=201), NovoLog® was added to basal insulin at the patient-perceived largest meal initially. In the full basal-bolus arm (n=200), NovoLog® was added at all 3 main meals from the start. Significantly more patients in the full basal-bolus arm (n=52) withdrew vs the stepwise arm (n=28) (P=0.002). There were no serious adverse events that led to withdrawal. Withdrawal criteria included: pregnancy or intention of becoming pregnant, hypoglycemia that posed a safety problem, major protocol deviation having influence on efficacy or safety data, and initiation or change in systemic treatment.
SMPG = self-measured plasma glucose