NovoLog® helps lower A1C levels1,2

The following studies demonstrated insulin intensification approaches using NovoLog® (insulin aspart [rDNA origin] injection) in a basal–bolus insulin regimen.

STEP-Wise™ Study

Indications and Usage NovoLog® (insulin aspart [rDNA origin] injection) is an insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus.

Important Safety Information NovoLog® is contraindicated during episodes of hypoglycemia and in patients hypersensitive to NovoLog® or one of its excipients. See More

NovoLog® offers glycemic control in a population of patients uncontrolled on a basal insulin

In the STEP-Wise™ study, patients uncontrolled on basal insulin were intensified to basal–bolus therapy with NovoLog® as the bolus insulin. After a 12-week run-in period with Levemir® (insulin detemir [rDNA origin] injection) as basal insulin, mealtime bolus injections were added sequentially, as needed to improve glycemic control—first at the patient-perceived largest meal, and then at the second patient-perceived largest meal, and finally at the third patient-perceived largest meal. (This was termed the “patient-perceived largest meal” approach.) Dosing began at 4 units of NovoLog® per injection, and the basal and bolus doses were titrated as the physician deemed appropriate. The study found that each additional injection improved A1C levels.

A1C reductions over 36 weeks with basal insulin plus NovoLog® in the patient-perceived largest meal approach1*†

*Basal insulin was titrated as needed per the study protocol.
†Baseline A1C was 8.7% at week 0.

A randomized, controlled, 48-week, multinational, treat-to-target trial of 296 patients with type 2 diabetes inadequately controlled on basal insulin and oral antidiabetic drugs (OADs) with 2 treatment approaches. NovoLog® was added either at the patient-perceived largest meal (n=150) and titrated based on the premeal and bedtime plasma glucose (PG), or at the meal with the highest postprandial increase (n=146; results not shown) and titrated based on 2-hour postprandial PG level.

Adapted from Meneghini et al, 2011.1

NovoLog® was titrated per the study protocol to reach premeal or bedtime goals

  • Adjustments were made by adding to or subtracting from the scheduled premeal dose

Mean total daily dose at the end of study for patient-perceived largest meal approach1‡

‡Total daily dose may vary and is usually between 0.5 to 1.0 units/kg/day.

An A1C reduction of 0.5% was seen after 12 weeks with just one bolus injection. An additional drop of 0.5% was seen at 24 weeks with up to 2 injections. Finally, an additional 0.2% drop was seen at 36 weeks with up to 3 injections.

When the study began, these patients had a duration of diabetes of about 12 years, and a mean A1C of about 8.7%.

  • In the patient-perceived largest meal approach, 77% of patients were on 3 bolus injections by the end of the study
  • 31% of patients in the patient-perceived largest meal approach achieved ADA A1C goal (<7%)1,3
  • The STEP-Wise™ trial resulted in an overall A1C reduction of 1.2%

Rates of hypoglycemia in the patient-perceived largest meal approach1*§ (episodes/year)

§ Minor hypoglycemia = symptoms with blood glucose <56 mg/dL; major symptoms required third-party assistant

The STEP-Wise study also examined rates of hypoglycemia

View Findings

4-T Study

Indications and Usage NovoLog® (insulin aspart [rDNA origin] injection) is an insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus.

Important Safety Information NovoLog® is contraindicated during episodes of hypoglycemia and in patients hypersensitive to NovoLog® or one of its excipients. See More

When intensified with NovoLog® in a basal-bolus regimen, a majority of patients attained and maintained A1C ≤7% within the 3-year study2,4

Another study, Treating to Target in Type 2 Diabetes (4-T), tried a second approach to intensifying to basal–bolus therapy: with basal insulin continued, 3 mealtime injections were added at once. Dosing began at 10% of the daily basal dose, between 4 and 6 units per meal. These patients were followed for 3 years and saw an A1C reduction of 1.2%. Sixty-three percent achieved the A1C goal of ≤7%.

Median total daily dose at the end of study2*†: 1.21 units/kg/day Levemir® (insulin detemir [rDNA origin] injection) + NovoLog®

  • 0.7 units/kg/day NovoLog®
  • 0.5 units/kg/day Levemir®

*Levemir® was initiated at beginning of study and NovoLog® was added 3x daily with each meal.
Doses of Levemir® and NovoLog® were titrated per study protocol.
†Total daily dose may vary and is usually between 0.5 to 1.0 units/kg/day.

A1C reductions over 3 years with Levemir® (insulin detemir [rDNA origin] injection) plus NovoLog®2‡

A 3-year, multicenter, randomized, treat-to-target study of 708 insulin-naïve patients with type 2 diabetes. A total of 234 patients were randomized to Levemir® and were intensified with NovoLog® if A1C was >10% after 1 measurement or ≥8% for 2 consecutive measurements at or after 24 weeks, or if A1C was >6.5% at 1 year. At study end, 82% of patients had been intensified with NovoLog®. The results of this arm of the study are shown here. In addition, 239 patients were randomized to NovoLog® and 235 patients were randomized to biphasic insulin aspart 30 (results not shown). All insulin was delivered by FlexPen®.2,4

Data are representative of all patients in the Levemir®-initiated arm.

‡ Baseline A1C was 8.4% ± 0.8%.4

Adapted from Holman et al, 2009.2

Hypoglycemic events2§ (number per patient per year)

§ Calculation based on median. Grade 2 (minor) symptoms with blood glucose <56 mg/dL; Grade 3 (major) required third-party assistance.

The 4-T study also examined rates of hypoglycemia

View Findings

PREFER Trial

Indications and Usage NovoLog® (insulin aspart [rDNA origin] injection) is an insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus.

Important Safety Information NovoLog® is contraindicated during episodes of hypoglycemia and in patients hypersensitive to NovoLog® or one of its excipients. See More

As part of a basal–bolus insulin regimen, NovoLog® achieved significant A1C reductions from baseline5

PREFER was a multinational treat-to-target trial that compared basal–bolus therapy, with NovoLog® as the bolus component, to a premix insulin regimen. Oral agents were discontinued, and dosing was titrated to fasting, predinner, or postprandial targets, as deemed clinically appropriate. NovoLog® in basal–bolus therapy reduced A1C by 1.56% over 26 weeks, to a mean A1C below the ADA goal of <7%.3,5

NovoLog® as part of a basal-bolus regimen achieved strong A1C reductions from baseline5

A 26-week, multicenter, randomized, treat-to-target trial that enrolled 719 patients with type 2 diabetes. Patients were randomized to either a basal-bolus regimen (insulin detemir + NovoLog®, n=541) or biphasic insulin aspart 30 (n=178). All OAD therapy was discontinued.5