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NovoLog® helps patients lower A1C levels1,2

NovoLog® is proven effective across a broad range of patients.
This page presents data from 3 trials in type 2 diabetes that
demonstrated significant reductions in A1C with NovoLog® in
a basal–bolus insulin regimen.

The STEP-Wise™ study

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® 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-largest meal, and finally at the third-largest meal.* (This was
termed the “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†‡

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

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

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 1 or 2 injections. Finally, an additional 0.2% drop was seen at 36 weeks with 1, 2, or 3 injections.

When the study began, these patients had a mean time since diagnosis of about
12 years, and a mean A1C of about 8.7%.

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

*Patient-perceived

In the STEP-Wise™ study, low rates of hypoglycemia were reported by patients intensified with NovoLog® in a basal–bolus regimen1

Sequential intensification with mealtime NovoLog® from a basal-only insulin regimen improved mean A1C, with low rates of hypoglycemia.

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

Rates of hypoglycemia in the largest-meal approach

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

*Patient-perceived.

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

Learn more about the STEP-Wise™ study:

View dosing and titration Watch eDetail

The 4-T study

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%.

A1C reductions over 3 years with Levemir®
plus NovoLog®2||

A1C reductions over 3 years with Levemir®

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

In the 4-T study, low rates of hypoglycemia were seen over 3 years
in patients intensifying to basal-bolus therapy with NovoLog®.2

Hypoglycemic events2|| (episodes/patient/year)

Hypoglycemic events

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

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

Learn more about the 4-T study:

View dosing and titration Watch eDetail

The PREFER trial

As part of a basal–bolus insulin regimen, NovoLog® achieved strong
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

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

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

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References:

  1. Meneghini L, Mersebach H, Kumar S, Svendsen AL, Hermansen K. Comparison of 2 intensification regimens with rapid-acting insulin aspart in type 2 diabetes mellitus inadequately controlled by once-daily insulin detemir and oral antidiabetes drugs: the step-wise randomized study. Endocr Pract. 2011;17(5):727-736.
  2. Holman RR, Farmer AJ, Davies MJ, et al; for the 4-T Study Group. Three-year efficacy of complex insulin regimens in type 2 diabetes. N Engl J Med. 2009;361(18):1736-1747.
  3. American Diabetes Association. Standards of medical care in diabetes–2011. Diabetes Care. 2011;34(suppl 1):S11-S61.
  4. Holman RR, Thorne KI, Farmer AJ, et al; for the 4-T Study Group. Addition of biphasic, prandial, or basal insulin to oral therapy in type 2 diabetes. N Engl J Med. 2007;357(17):1716-1730.
  5. Liebl A, Prager R, Binz K, Kaiser M, Bergenstal R, Gallwitz B; for the PREFER Study Group. Comparison of insulin analogue regimens in people with type 2 diabetes mellitus in the PREFER Study: a randomized controlled trial. Diabetes Obes Metab. 2009;11(1):45-52.

  1. Levemir® (insulin detemir [rDNA origin] injection) Indications and Usage

    Levemir® is indicated for once- or twice-daily subcutaneous administration for the treatment of adult and pediatric patients with type 1 diabetes mellitus or adult patients with type 2 diabetes mellitus who require basal (long-acting) insulin for the control of hyperglycemia.

    Levemir® Important Safety Information

    Levemir® is contraindicated in patients hypersensitive to insulin detemir or one of its excipients.

    Levemir® should not be diluted or mixed with any other insulin preparations.

    Hypoglycemia is the most common adverse effect of all insulin therapies, including Levemir®. As with other insulins, the timing of hypoglycemic events may differ among various insulin preparations. Glucose monitoring is recommended for all patients with diabetes. Levemir® is not to be used in insulin infusion pumps. Any change of insulin dose should be made cautiously and only under medical supervision. Concomitant oral antidiabetes treatment may require adjustment.

    Needles and Levemir® FlexPen® must not be shared.

    Inadequate dosing or discontinuation of treatment may lead to hyperglycemia and, in patients with type 1 diabetes, diabetic ketoacidosis. Insulin may cause sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy. Dose and timing of administration may need to be adjusted to reduce the risk of hypoglycemia in patients being switched to Levemir® from other intermediate or long-acting insulin preparations. The dose of Levemir® may need to be adjusted in patients with renal or hepatic impairment.

    Other adverse events commonly associated with insulin therapy may include injection site reactions (on average, 3% to 4% of patients in clinical trials) such as lipodystrophy, redness, pain, itching, hives, swelling, and inflammation. Less common but more serious are severe cases of generalized allergy, including anaphylactic reaction, which may be life threatening.

    *Whether these observed differences represent true differences in the effects of Levemir®, NPH insulin, and insulin glargine is not known since these trials were not blinded and the protocols (e.g., diet and exercise instructions and monitoring) were not specifically directed at exploring hypotheses related to weight effects of the treatments compared. The clinical significance of the observed differences in weight has not been established.

    Please click hereclick here for Prescribing Information.

  2. NovoLog® (insulin aspart [rDNA origin] injection) Indications and Usage

    NovoLog® is an insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus.

    NovoLog® Important Safety Information

    NovoLog® is contraindicated during episodes of hypoglycemia and in patients hypersensitive to NovoLog® or one of its excipients.

    NovoLog® has a more rapid onset and shorter duration of action than regular human insulin. An injection of NovoLog® should be immediately followed by a meal within 5 to 10 minutes. Because of the short duration of action of NovoLog®, a longer-acting insulin also should be used in patients with type 1 diabetes and may be needed in patients with type 2 diabetes. When used in an external subcutaneous insulin infusion pump, NovoLog® should not be mixed with any other insulin or diluent. Hypoglycemia is the most common adverse effect of all insulin therapies, including NovoLog®. The timing of hypoglycemia usually reflects the time-action profile of the administered insulins.

    Any change of insulin dose should be made cautiously and only under medical supervision. Glucose monitoring is recommended for all patients with diabetes and is particularly important for patients using external pump infusion therapy. As with all insulin preparations, the time course of action of NovoLog® may vary in different individuals or at different times in the same individual and is dependent on many conditions, including injection site, local blood supply, temperature, and level of physical activity.

    Needles and NovoLog® FlexPen® must not be shared.

    NovoLog® has not been studied in children with type 2 diabetes or in children with type 1 diabetes under the age of two.

    Severe, life-threatening generalized allergy, including anaphylactic reaction, may occur with any insulin product, including NovoLog®. Adverse reactions observed with NovoLog® include hypoglycemia, allergic reactions, local injection site reactions, lipodystrophy, rash, and pruritus. Insulin, particularly when given intravenously or in settings of poor glycemic control, may cause hypokalemia. Like all insulins, NovoLog® requirements may be reduced in patients with renal impairment or hepatic impairment.

    Please click hereclick here for Prescribing Information.

  3. NovoLog® Mix 70/30 (70% insulin aspart protamine suspension and 30% insulin aspart injection, [rDNA origin]) Indications and Usage

    NovoLog® Mix 70/30 (70% insulin aspart protamine suspension and 30% insulin aspart injection, [rDNA origin]) is an insulin analog indicated to improve glycemic control in patients with diabetes mellitus.

    Important Limitations of Use:
    In premix insulins, such as NovoLog® Mix 70/30, the proportions of rapid acting and long acting insulins are fixed and do not allow for basal versus prandial dose adjustments.

    NovoLog® Mix 70/30 Important Safety Information

    NovoLog® Mix 70/30 is contraindicated during episodes of hypoglycemia and in patients hypersensitive to NovoLog® Mix 70/30 or one of its excipients.

    NovoLog® Mix 70/30 has a faster onset of action than human insulin premix 70/30 and should be dosed within 15 minutes before meal initiation for patients with type 1 diabetes. For patients with type 2 diabetes, dosing should occur within 15 minutes before or after meal initiation.

    NovoLog® Mix 70/30 should not be administered intravenously or used in insulin infusion pumps. NovoLog® Mix 70/30 should not be mixed with any other insulin product.

    Hypoglycemia is the most common adverse effect of insulin therapy, including NovoLog® Mix 70/30. The timing of hypoglycemia may reflect the time-action profile of the insulin formulation. Glucose monitoring is recommended for all patients with diabetes. Any change of insulin should be made cautiously and only under medical supervision.

    Needles and NovoLog® Mix 70/30 FlexPen® must not be shared.

    Severe, life-threatening generalized allergy, including anaphylaxis, may occur with insulin products, including NovoLog® Mix 70/30. Adverse reactions observed with NovoLog® Mix 70/30 include hypoglycemia, allergic reactions, local injection site reactions, lipodystrophy, rash, and pruritus. Insulin, particularly when given in settings of poor glycemic control, may cause hypokalemia. Like all insulins, NovoLog® Mix 70/30 requirements may be reduced in patients with renal impairment or hepatic impairment.

    The safety and effectiveness of NovoLog® Mix 70/30 has not been established in pediatric patients. Clinical studies of NovoLog® Mix 70/30 did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently than younger patients.

    The significance, with respect to the long-term clinical sequelae of diabetes, of the differences in postprandial hyperglycemia between treatment groups has not been established.

    Please click hereclick here for Prescribing Information.

FlexPen®, Levemir®, and NovoLog® are registered trademarks of Novo Nordisk A/S.
NovoMedLink™ is a trademark of Novo Nordisk A/S.
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