Study Shows Gradual Addition of NovoLog® at Mealtime Can Reduce A1c in Type 2 Diabetes Patients

ORLANDO, Fla., June 28 /PRNewswire-FirstCall/ -- Today Novo Nordisk announced results of its STEPwise™ trial, which identified a method of intensifying insulin treatment with NovoLog® (insulin aspart [rDNA origin] injection). The study, presented at the American Diabetes Association (ADA) 2010 Scientific Sessions, demonstrated a reduction of A1c levels in type 2 diabetes patients when a dose of NovoLog® was introduced at meals, using two approaches that start with the largest meal of the day, in addition to once-daily Levemir® (insulin detemir [rDNA origin] injection) plus oral medications.

The 48-week open-label, randomized, multinational trial compared two step-wise methods of gradually intensifying treatment with NovoLog® in patients with type 2 diabetes taking once-daily Levemir® plus oral medication:

1. "SimpleSTEP" (fewer blood sugar measurements): Patients were given their first routine daily dose of NovoLog® at their largest meal and additional doses of NovoLog® were added in sequence based on their blood sugar levels before the meal
2. "ExtraSTEP" (more frequent blood sugar measurements): Patients were given their first routine daily dose of NovoLog® at the meal with the largest increase in blood sugar before and after the meal, and adjusted the dose amount based on the amount of rise in blood sugar before and after the meal

After 12 weeks, patients in either arm who had an A1c of greater than 7% received a second dose of NovoLog® at another meal. At 24 weeks, patients were held to the same A1c targets and given a dose of NovoLog® at a third meal if A1c was still greater than 7%. After 48 weeks, investigators concluded that the step-wise addition of NovoLog® to Levemir® plus oral medication, as outlined in the study, can be equally effective, whether using a more intuitive approach (like SimpleSTEP) or one with more frequent, precise measurements of blood sugar levels (like ExtraSTEP), for intensifying therapy in patients with type 2 diabetes to lower A1c levels.  

"A significant challenge for physicians treating patients with type 2 diabetes is figuring out how to introduce a meal-time insulin when basal insulin with or without oral medications is no longer enough to keep blood sugar levels stable," said Luigi Meneghini, M.D., M.B.A., lead investigator in the STEPwise™ trial, Professor of Clinical Medicine at the University of Miami Miller School of Medicine. "With the SimpleSTEP and ExtraSTEP algorithms, we have identified an approach for how to gradually introduce and intensify doses of NovoLog® at mealtimes in patients who increasingly need glucose control as their diabetes progresses."

More details of the study will be presented at the American Diabetes Association's Scientific Sessions in Orlando, FL on Monday, June 28 during Poster Session III, 12:00-2:00  p.m. in the Orange County Convention Center, Hall C.

About the STEPwise Trial(1)

The trial involved 296 patients, at an average age of 58 and mean A1c of 8.8% on basal insulin and oral medications. The primary efficacy endpoint was HbA1c after 36 weeks of treatment. Treatment was given with Levemir® FlexPen® once daily in combination with NovoLog® FlexPen® one to three times daily, before meals, with the dose adjusted individually based on defined titration guidelines developed for the study.

• The mean observed HbA1c after 36 weeks of treatment was 7.7% in the ExtraSTEP treatment group and 7.5% in the SimpleSTEP treatment group.
• The mean (absolute) change in HbA1c was -1.3% in the ExtraSTEP treatment group and -1.1% in the SimpleSTEP treatment group.

Prescribing information for Levemir® and NovoLog® is available by contacting Novo Nordisk at 1-800-727-6500 or visiting Levemir-us.com and NovoLog.com.

About Levemir® and NovoLog®

Levemir® (insulin detemir [rDNA origin] injection) is a man-made long-acting insulin that is used to control high blood sugar in adults and children with diabetes mellitus.

NovoLog® (insulin aspart [rDNA origin] injection) is a man-made insulin that is used to control high blood sugar in adults and children with diabetes mellitus.

Important Safety Information for Levemir®  

Do not take Levemir® if your blood sugar is too low (hypoglycemia) or if you are allergic to anything in Levemir®.  If you take too much Levemir® your blood sugar may fall too low.

Check your blood sugar levels. Ask your health care provider what your blood sugars should be and when you should check your blood sugar levels. Alcohol, including beer and wine, may affect your blood sugar when you take Levemir®.

Do not change the type of insulin you use unless told to do so by your health care provider. The amount of insulin you take as well as the best time for you to take your insulin may need to change if you take a different type of insulin.

Never mix Levemir® with other insulin products or use in an insulin pump.

Needles and Levemir® FlexPen® must not be shared.

Tell your health care provider about all medicines you take and all of your medical conditions, including if you are pregnant or breastfeeding. Your Levemir® dose may change if you take other medicines.

The most common side effect of Levemir® is low blood sugar (hypoglycemia). Other possible side effects include reactions at the injection site (like redness, swelling and itching), and allergic reactions. Get medical help right away if you experience signs of serious allergic reaction such as body rash, trouble with your breathing, fast heartbeat, or sweating. Ask your doctor or pharmacist for further information.

Important Safety Information for NovoLog®

Do not take NovoLog® if your blood sugar is too low (hypoglycemia) or if you are allergic to anything in NovoLog®. If you take too much NovoLog® your blood sugar may fall too low.

NovoLog® is a fast-acting insulin. You should eat a meal within 5 to 10 minutes after using NovoLog® to avoid low blood sugar. Do not inject NovoLog® if you do not plan to eat right after using NovoLog®. Check your blood sugar levels. Ask your health care provider what your blood sugars should be and when you should check your blood sugar levels. Alcohol, including beer and wine, may affect your blood sugar when you take NovoLog®.

Do not change the type of insulin you use unless told to do so by your health care provider. The amount of insulin you take as well as the best time for you to take your insulin may need to change if you take a different type of insulin.

Do not mix NovoLog® with any other insulins when used in a pump or with any insulins other than NPH when used with injections by syringe.

Needles and NovoLog® FlexPen® must not be shared.

Tell your health care provider about all medicines you take and all of your medical conditions, including if you are pregnant or breastfeeding. Your NovoLog® dose may change if you take other medicines.

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

The most common side effect of NovoLog® is low blood sugar (hypoglycemia). Other possible side effects include reactions at the injection site (like redness, swelling and itching), and allergic reactions. Get medical help right away if you experience signs of serious allergic reaction such as body rash, trouble with your breathing, fast heartbeat, or sweating. Ask your doctor or pharmacist for further information.

FlexPen®, Levemir®, and NovoLog® are registered trademarks of Novo Nordisk A/S.

About Novo Nordisk

Novo Nordisk is a global healthcare company with more than 87 years of innovation and leadership in diabetes care. The company also has leading positions within hemophilia care, growth hormone therapy and hormone therapy for women. Novo Nordisk's business is driven by the Triple Bottom Line: a commitment to social responsibility to employees and customers, environmental soundness and economic success. Headquartered in Denmark, Novo Nordisk employs more than 29,000 employees in 81 countries, and markets its products in 179 countries. Novo Nordisk's B shares are listed on the stock exchanges in Copenhagen and London. Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk-us.com.

(1)  Meneghini, L. et al. Treatment Intensification by Stepwise Addition of Prandial Insulin Aspart to Once-Daily Basal Insulin Detemir in Subjects with Type 2 Diabetes: The STEPwise™ Trial [abstract]. Diabetes. 2010;59(suppl 1). http://ww2.aievolution.com/ada1001/index.cfm?do=abs.viewAbs&abs=13431. Accessed June 17, 2010.

SOURCE Novo Nordisk