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New Long-Acting Basal Insulin Analog Is Now Available

PRINCETON, N.J., March 28 /PRNewswire-FirstCall/ -- Novo Nordisk Inc. today announced that Levemir(R) (insulin detemir [rDNA origin] injection), a new long-acting basal insulin analog is now commercially available in the United States. Levemir is indicated for once- or twice-daily injection for the treatment of adults and children with type 1 diabetes and adults with type 2 diabetes. The relatively flat action profile of Levemir offers patients up to 24 hours of effective blood glucose control. In a clinical trial, 70 percent of Levemir patients achieved the target A1C level of less than or equal to 7 percent, a significant achievement in getting patients to goal. Levemir is the first basal insulin analog to have a treat-to-target study in its label.

Weight gain and hypoglycemia (low blood sugar) are common side effects of insulin therapy and are key barriers to patients reaching better glycemic control. Importantly, Levemir offers a low rate of hypoglycemia and is the first insulin to demonstrate consistently less weight gain in 12 out of 12 controlled clinical trials.

"Diabetes is currently one of the most serious health challenges affecting people worldwide with millions of Americans living with diabetes in poor control. The availability of Levemir offers patients an important new long-acting insulin analog with effective glycemic control -- while addressing physician and patient concerns of weight gain and hypoglycemia. Accuracy and ease-of-use can be obtained with Levemir in FlexPen, the convenient insulin delivery system," said Martin Soeters, president Novo Nordisk Inc. "As the world's leading provider of insulin, we are dedicated to improving diabetes care, and with the addition of Levemir are proud to be the first and only company in the US offering a complete portfolio of insulin analogs to meet individual patient needs."

Following is summary data from clinical studies of Levemir:

* In 12 of 12 controlled clinical trials of more than 6,000 patients with type 1 and type 2 diabetes, Levemir resulted in less weight gain.

* The average weight gain of Levemir patients was almost 3 times less than that of patients taking NPH insulin in a 24-week clinical trial of patients with type 2 diabetes taking oral agents.

* A low incidence of minor hypoglycemia was also observed in 4 of 4 pivotal studies in adults, as well as a relatively low incidence of major hypoglycemia in 3 of these studies.

* In one study, patients taking Levemir were nearly half as likely to experience a minor hypoglycemic event than patients taking NPH insulin.

* The safety and efficacy of Levemir given once or twice daily was found to be comparable to NPH human insulin or insulin glargine in controlled clinical studies.

"Novo Nordisk has had an extensive development program for Levemir resulting in a robust clinical package," said Peter Aurup, MD, vice president of clinical development, medical & regulatory affairs, Novo Nordisk Inc. "We are very pleased with the positive clinical outcomes seen to date with Levemir and the acknowledgement of the product's offerings in the label and promotional materials as reviewed by the FDA."

Levemir is available in vials and Levemir FlexPen(R). FlexPen is the preferred prefilled insulin pen by patients.(1),(2) In preparation for patient availability the product began shipping to retailers on March 6 with a goal of having Levemir on the shelves of 44,000 retail outlets by March 17.

About Diabetes
Diabetes, a disease in which the body does not produce or properly use insulin, affects 20.8 million people in the US or seven percent of the population. Of those living with the disease 6.2 million people (or nearly one-third) are unaware that they have the condition, and of those who have been diagnosed 10 million are in poor control.(3) Diabetes is the sixth leading cause of death by disease in the US and costs an estimated $132 billion per year in medical expenses and lost productivity.(4),(5) According to the World Health Organization, the total number of people with diabetes worldwide is projected to rise from 171 million in 2000 to 366 million in 2030.(6)

Type 1 diabetes results from the body's failure to produce insulin, the hormone that "unlocks" the cells of the body, allowing glucose to enter and fuel them. It is estimated that 5-10 percent of Americans who are diagnosed with diabetes have type 1 diabetes. Type 2 diabetes results from insulin resistance (a condition in which the body fails to properly use insulin), combined with relative insulin deficiency. Most Americans who are diagnosed with diabetes have type 2 diabetes. Research studies in the United States and abroad have found that improved glycemic control benefits people with either type 1 or type 2 diabetes.(3)

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 US Food and Drug Administration in June 2005 and is currently approved in 50 countries worldwide. Levemir was developed by Novo Nordisk A/S and is marketed in the US by Novo Nordisk Inc.

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.

(1) Niskanen L, Jensen LE, Rastam J, Nygaard-Pedersen L, Erichsen K, Vora JP. Randomized, multinational, open-label, 2-period, crossover comparison of biphasic insulin aspart 30 and biphasic insulin lispro 25 and pen devices in adult patients with type 2 diabetes mellitus. Clinical Therapeutics 2004:26 [no 4]:531-540.

(2) IMS Health, data collected for the 12 months ending September 2005.

(3) Centers for Disease Control and Prevention, National Diabetes Fact Sheet 2005. Available at: https://www.cdc.gov/diabetes/pubs/pdf/ndfs_2005.pdf. Accessed March 2006.

(4) National Diabetes Statistics, National Diabetes Information Clearing House, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), NIH. Available at: https://www.niddk.nih.gov/health-information/diabetes. Accessed March 2006.

(5) American Diabetes Association. Economic Costs of Diabetes in the US in 2002, Diabetes Care. Available at https://care.diabetesjournals.org/content/26/3/917.full. Accessed June 10, 2005.

(6) World Health Organization. Global Prevalence of Diabetes: Estimates for the year 2000 and projections for 2030. Available at https://www.who.int/diabetes/facts/en/diabcare0504.pdf. Accessed June 10, 2005.

Source: Novo Nordisk Inc.

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