Intensifying with NovoLog^®—
the STEP-Wise^TM approach

For patients with type 2 diabetes on basal insulin
with uncontrolled A1C levels

Patients with type 2 diabetes who have uncontrolled A1C levels despite
at-target fasting glucose, and who have uncontrolled postprandial glucose
levels, may benefit from adding NovoLog^® at mealtimes to address
postprandial glucose spikes. Of the numerous approaches to insulin
intensification that have been studied in clinical trials, this website
describes two in detail: adding mealtime injections to a bolus regimen
sequentially, as needed (the STEP-WiseTM approach, below), or adding
three mealtime injections at once (the 4-T approach).

Intensify to a basal–bolus regimen using the
STEP-Wise^™ approach

Approach to intensify with Novolog^®1

Levemir^® could also be further titrated. Patients did not self-titrate in the STEP-Wise^™
study. Instead, physicians made dose adjustments based on blood glucose averages
reported weekly by patients.

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.¹

STEP-Wise^™ dose adjustments¹

• Patients did not self-titrate in the STEP-Wise^™ study
• In the patient-percieved largest-meal approach, premeal PG goal
  was 72 to 108 mg/dL and bedtime PG goal was 72 to 144 mg/dL
• When levels were outside the premeal target, prior adjustments were
  made by adding to or subtracting from the scheduled premeal dose

Patients in the patient-percieved largest meal approach measured 3 4-point
self-monitored plasma glucose (SMPG) profiles:

• Before breakfast, lunch, dinner, and at bedtime
• Within a week prior to each weekly appointment

By doing so, dose adjustments could be made based on the average of 3
glucose measurements a week, tested 4 times a day. Patients could measure
any 3 days of the week. NovoLog^® doses at breakfast and lunch were
adjusted on the basis of the SMPG measured before lunch and dinner,
respectively. Adjustment of the NovoLog^® dose at dinner was based on the
bedtime measurements.

An example of STEP-Wise^™ dose adjustments is shown below:

Patients’ basal and NovoLog^® doses were adjusted using the following chart
based on their reported SMPG averages.

Basal^* dose adjustments¹

NovoLog^® dose adjustments

^* Basal insulin in this study was Levemir^® (insulin detemir [rDNA origin] injection).

^† One or more prandial blood glucose values <72 mg/dL (4.0 mmol/L) without obvious explanation.

^‡ Patients were allowed to make daily adjustments to their insulin dose based on
changes in meal content, physical activity level, and blood glucose measurements.

Please note that these are general guidelines.
Glycemic management should be individualized for each patient.