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Levemir Helps Patients Significantly and Safely Improve Control in a Real World Study

Study supports evidence of improved control while maintaining weight neutrality in actual clinical practice - in one of the largest worldwide observational diabetes studies to date - with data from more than 10,000 patients

WASHINGTON, DC -- June 21, 2006 -- Novo Nordisk announced results from the German cohort of 10,276 patients enrolled in the observational PREDICTIVE(TM) trial, which found Levemir(R) (insulin detemir [rDNA origin] injection) improved blood sugar control (A1C) and reduced episodes of major hypoglycemia (low blood sugar) with no weight gain in actual clinical practice.

The primary endpoint was safety. These results and the findings of a separate sub-group analysis were presented at the 66th Scientific Sessions of the American Diabetes Association (ADA) in Washington, D.C.

In PREDICTIVE, Levemir demonstrated significant improvement in blood sugar control - A1C levels were reduced significantly in both type 1 and type 2 diabetes patients. In addition, patients with type 2 diabetes lost weight, while type 1 patients maintained their weight while using Levemir. Weight gain is a common side effect of insulin therapy(1) and Levemir is the first insulin to show less weight gain versus other basal insulins in 12 of 12 controlled clinical trials. Among people with diabetes, 90 to 95 percent have type 2 diabetes(2) and 80 percent of people with diabetes are overweight or obese(3).

Additionally, an analysis of a sub-group of this study of type 2 diabetes patients (n=511) focused on patients who switched from NPH or glargine to Levemir. These patients experienced significant improvement in A1C, and reduced episodes of major hypoglycemia. Both patient groups also experienced weight reduction.

"Novo Nordisk continues to make a difference by bringing innovative treatments to meet the individual needs of the growing number of people living with diabetes," said Alan Moses, Associate Vice President of Clinical Research and Medical Affairs at Novo Nordisk. "The recent addition of Levemir to our robust diabetes portfolio should not only help patients reach recommended A1C levels, but may also help physicians break down barriers to initiating insulin therapy."

PREDICTIVE Study Key Findings (Poster# 511-P)
PREDICTIVE (Predictable Results and Experience in Diabetes through Intensification and Control to Target: An International Variability Evaluation), a multi-center observational study, is assessing the safety and efficacy of Levemir and providing insights into different treatment patterns and blood sugar control. The primary endpoint of the study was safety, including the incidence of major hypoglycemic events. The findings are from the German cohort of 10,276 patients (26 percent type 1, 73 percent type 2, 1 percent other classification), with a mean follow-up period of 14.5 weeks after initiation of Levemir:

-- Levemir reduced mean A1C levels by 0.54 percent for type 1 and 0.89 percent for type 2 diabetes patients (P <.001 for both)
-- Episodes of major hypoglycemia were significantly reduced in type 1 patients and as well as type 2 patients. In type 1 patients, major hypoglycemic episodes dropped from 1.08 per patient year in the four weeks prior to study start to 0.12 per patient year in the four weeks before follow-up (P <.001). In type 2 patients, major episodes dropped from 0.3 to 0.06 per patient year (P <.001)
-- Twenty eight serious adverse drug reactions were reported during the follow up period of 14.5 weeks, the majority of which were hypoglycemic episodes
-- Type 1 patients gained no weight and type 2 patients experienced a slight reduction in body weight during the study (-0.6kg, P <.001)
-- 73 percent of type 2 patients used Levemir once daily

"With the prevalence of diabetes expected to exceed 333 million by 2025(4), this study not only provides us with an opportunity to validate the benefits of Levemir in clinical practice but it will also provide valuable information about diabetes treatment patterns and glycemic control," said Dr. Hans-Joachim Luddeke, an investigator in the PREDICTIVE study in Munich, Germany. "This will help to inform further improvements in the management of this potential pandemic."

In the sub-group analysis of patients with type 2 diabetes who switched from NPH (n=251) or glargine (n=260) to Levemir (Poster# 614-P), A1C was reduced by 0.57 percent and 0.58 percent, respectively. In these patients, no major hypoglycemia was observed for Levemir (NPH insulin switches decreased from 0.4 to 0/patient years, insulin glargine switches decreased from 0.3 to 0/patients years). Furthermore, patients in both groups switching from NPH and glargine experienced slight weight reduction (-0.9 kg and -0.8 kg, respectively).

Novo Nordisk recently initiated the PREDICTIVE 303 study in the U.S. to investigate a simple self-titration algorithm to help patients achieve their A1C targets with Levemir.

About Levemir
Levemir (insulin detemir [rDNA origin] injection) is a long-acting basal insulin analog indicated for once- or twice-daily subcutaneous administration for the treatment of adults and children with type 1 diabetes mellitus and adult patients with type 2 diabetes mellitus who require basal (long-acting) insulin for the control of hyperglycemia. Levemir has a relatively flat action profile with up to 24 hours duration of action. It can be added to oral anti-diabetic agents, or used in combination with a rapid-acting insulin. Levemir is available in FlexPen, a prefilled disposable insulin pen for easy, discreet dosing, and in vials.

Levemir was approved by the U.S. Food and Drug Administration in June 2005 and is currently approved in 50 countries worldwide. Levemir is contraindicated in patients hypersensitive to insulin detemir or its excipients. Hypoglycemia is the most common adverse effect of all insulin therapies, including Levemir. As with all insulins, the timing of hypoglycemic events may differ among various insulin formulations. Glucose monitoring is recommended for all patients with diabetes. Other adverse events commonly associated with insulin therapy may include injection site reactions (on average 3-4% of patients in clinical trials) such as lipodystrophy, redness, pain, itching, hives, swelling, or inflammation.

Any change of insulin dose should be made cautiously and only under medical supervision. Levemir should not be diluted or mixed with any other insulin preparations or used in insulin infusion pumps. Whether the observed differences in weight represent true differences in the effects of Levemir and NPH insulin 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 has not been established.

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

REFERENCES:
(1) Facts on file, Novo Nordisk, Princeton, NJ
(2) National Diabetes Information Clearinghouse (NDIC), Diabetes Overview. Available at: http://www.diabetes.niddk.nih.gov/dm/pubs/overview/index.htm#types. NIH Publication No. 06-3873, April 2006.
(3) United States Department of Health and Human Services, Overweight and Obesity: Health Consequences Fact Sheet. Available at: http://www.surgeongeneral.gov/topics/obesity/calltoaction/fact_consequences.htm Accessed June 2006.
(4) The International Diabetes Federation: Diabetes Atlas. Available at: http://www.eatlas.idf.org/prevalence.htm Accessed at June 2006.


SOURCE: Novo Nordisk

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