Patients with type 2 diabetes who intensify with bolus insulin step by step obtain the same glycemic control as patients following a full basal-bolus treatment from the start

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Jun 24, 2013, 10:00 ET

CHICAGO, June 24, 2013 /PRNewswire/ -- Patients with type 2 diabetes, who are inadequately controlled on basal insulin plus oral anti-diabetic medications (OADs), obtained comparable reduction in A1c, whether they intensified with bolus insulin treatment step by step, or followed a full basal-bolus treatment with every meal from the start. Novo Nordisk presented data from the Full STEP™ study today at the 73^rd Scientific Sessions of the American Diabetes Association (ADA).

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Findings also showed that step-wise intensification of mealtime insulin therapy—adding doses over a period of several weeks—resulted in a significantly lower rate of hypoglycemia compared with a full basal-bolus intensification. At the end of the trial, almost half (44.8%) of the patients following the step-wise regimen only required 1 or 2 mealtime injections a day.

"These findings have a considerable importance for the treatment of type 2 diabetes," said Dr. Helena W. Rodbard, the study's primary investigator. "Step-wise intensification was associated with a significantly lower rate of hypoglycemia, and should enable many patients to achieve the same glycemic control as with a full basal-bolus regimen."

Patients following the full basal-bolus treatment regimen received NovoLog^® (insulin aspart [rDNA origin] injection) before each meal, in addition to taking a basal insulin, for the entire trial. In the step-wise group, patients taking basal insulin initially received only one bolus dose administered with the largest meal, and after 11 and 22 weeks, respectively, added a second and/or a third bolus dose with the other meals if A1c remained greater than or equal 7%.¹

Findings of the Full STEP^™ study include:

Compared with a full basal-bolus treatment regimen, step-wise intensification of mealtime insulin therapy led to a significantly lower rate of hypoglycemia (P<0.001).¹
The drop-out rate was 14% among patients in the step-wise group compared with 26% among patients in the basal-bolus group.¹
Both treatment regimens succeeded in lowering A1c levels to the same extent. The change from baseline A1c was -0.98% after 32 weeks in the step-wise treatment group, compared with -1.12% in the basal-bolus group (not statistically significant).¹

The most common adverse events of greater than or equal to 5% are nasopharyngitis, influenza, diarrhea, headache, peripheral edema, and wrong drug administered.

About the Full STEP™ study

Full STEP™ is a randomized, multinational, 32-week treat-to-target trial conducted among 401 people with type 2 diabetes inadequately controlled on basal insulin and OADs (A1c 7-9%). The study was conducted in 7 countries (Argentina, Brazil, Canada, France, Macedonia, Slovenia, and the United States). In the trial they received Levemir^® (insulin detemir [rDNA origin] injection) adding NovoLog^®either with every meal or starting with the largest meal only, and then adding 1 or 2 additional doses to the other meals if HbA1C remained greater than equal to 7%.

About NovoLog^®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.

NovoLog^® (insulin aspart [rDNA origin] injection) should generally be given immediately (within 5-10 minutes) prior to the start of a meal. 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. NovoLog^® should be used with a longer-acting insulin. 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 insulin therapy. The timing of hypoglycemia may reflect the time-action profile of the insulin formulation. Glucose monitoring is recommended for all patients with diabetes and is particularly important for patients using external pump infusion therapy. Any change of insulin dose should be made cautiously and only under medical supervision.

Insulin, particularly when given intravenously or in settings of poor glycemic control, can cause hypokalemia. Use caution in patients predisposed to hypokalemia.

Like all insulins, NovoLog^® requirements may be reduced in patients with renal impairment or hepatic impairment.

Severe, life-threatening, generalized allergy, including anaphylaxis, may occur with insulin products, including NovoLog^®.

Fluid retention and heart failure can occur with concomitant use of thiazolidinediones (TZDs), which are PPAR-gamma agonists, and insulin, including NovoLog^®.

Adverse reactions observed with NovoLog^® include hypoglycemia, allergic reactions, local injection site reactions, lipodystrophy, rash, and pruritus.

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 who are younger than 2 years of age.

The background risk of birth defects, pregnancy loss, or other adverse events that exists for all pregnancies is increased in pregnancies complicated by hyperglycemia.

For full Prescribing Information, please see www.novolog.com.

About Levemir^®
Indications and Usage

Levemir^® (insulin detemir [rDNA origin] injection) is indicated to improve glycemic control in adults and children with diabetes mellitus.

Important Limitations of Use
Levemir^® is not recommended for the treatment of diabetic ketoacidosis. Intravenous rapid-acting or short-acting insulin is the preferred treatment for this condition.

Important Safety Information

Levemir^® is contraindicated in patients with hypersensitivity to Levemir^® or any of its excipients.

Monitor blood glucose in all patients treated with insulin. Insulin regimens should be modified cautiously and only under medical supervision.

Do not dilute or mix with any other insulin or solution. Do not administer subcutaneously via an insulin pump, intramuscularly, or intravenously because severe hypoglycemia can occur.

Hypoglycemia is the most common adverse reaction of insulin therapy and may be life threatening. When a GLP-1 receptor agonist is used in combination with Levemir^®, the Levemir^® dose may need to be lowered or more conservatively titrated to minimize the risk of hypoglycemia. Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulin products, including Levemir^®.

Careful glucose monitoring and dose adjustments of insulin, including Levemir^®, may be necessary in patients with renal or hepatic impairment.

Fluid retention and heart failure can occur with concomitant use of thiazolidinediones (TZDs), which are PPAR-gamma agonists, and insulin, including Levemir^®.

Adverse reactions associated with Levemir^® include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, rash, pruritus, and if taken with GLP-1 receptor agonist, diarrhea.

Needles and Levemir^® FlexPen^® should never be shared.

Levemir^® (insulin detemir [rDNA origin] injection) has not been studied in children with type 2 diabetes or in children with type 1 diabetes who are younger than 2 years of age.

The background risk of birth defects, pregnancy loss, or other adverse events that exists for all pregnancies is increased in pregnancies complicated by hyperglycemia.

For full Prescribing Information, please see www.levemir.com.

About Novo Nordisk
Headquartered in Denmark, Novo Nordisk is a global health care company with 90 years of innovation and leadership in diabetes care. The company also has leading positions within hemophilia care, growth hormone therapy and hormone replacement therapy. For more information, visit novonordisk-us.com or follow our news in the US on Twitter: @NovoNordiskUS.

¹ Rodbard HW, Visco VE, Shu DHW, et al; Intensification of Basal Insulin Therapy with Step-wise Addition of Insulin Aspart Boluses vs. Basal-bolus Therapy: The Full STEP™ Study. Oral presentation #256-OR, ADA 24 June 2013.

SOURCE Novo Nordisk