Study Demonstrates Long-Term Efficacy and Safety of NovoLog(R) Mix 70/30 in Type 2 Diabetes as Compared to Biphasic Human Insulin 30

According to a two-year head-to-head study published today in the European Journal of Internal Medicine, patients with type 2 diabetes showed reduced incidences of major hypoglycemia when using Novolog® Mix 70/30 (70% insulin aspart protamine suspension and 30% insulin aspart injection, [rDNA origin]) versus biphasic human insulin 30 (Novolin® 70/30, 70% NPH, human insulin isophane suspension and 30% regular, human insulin injection [rDNA origin]) (0% vs. 10%, p=0.04)) with comparable efficacy.(1)

"It appears that NovoLog® Mix 70/30 is a useful pharmacological tool that can help to redress the balance between hypoglycemia and hyperglycemia in the daily challenge to manage blood glucose levels in type 2 diabetes," concluded Bernhard Böhm,M.D.,Ph.D. Department of Internal Medicine, University of Ulm, Germany and lead investigator of the study.

Symptoms associated with hypoglycemia, a condition that develops when blood glucose levels are critically low due to inappropriately matched levels of injected insulin, include disorientation, delirium, loss of consciousness, and in severe cases, coma and death.

"The use of insulin in type 2 diabetes patients remains a barrier for many physicians and many patients. The ability to achieve comparable levels of glucose control with a premixed analog insulin and premixed human insulin but with a lower risk of major hypoglycemia as shown in European Journal of Internal Medicine report is significant," said Alan Moses, M.D., associate vice president of medical affairs, Novo Nordisk Inc.

The two-year study, performed at 30 centers in Germany, was comprised of a three-month initial period followed by a 21-month extension period. During the study, 190 type 2 patients were randomized to receive NovoLog® Mix 70/30 or Novolin® 70/30 twice daily with their morning and evening meals, for a period of three months. A total of 125 (72%) type 2 patients entered the 21-month extension. Patients entering the initial treatment period had type 2 diabetes for more than 24 months, were aged 18 years or older, and had an A1C level equal to or below 11%. Outcome measures for the initial study included postprandial and daily blood glucose control and hypoglycemia. Patients attended screening visits at regular intervals, and were assessed for long-term safety in terms of hypoglycemia and, secondarily, by adverse events.

"We found that patients treated with NovoLog® Mix 70/30 experienced fewer major hypoglycemic events in the second year of the study, despite having similar levels of metabolic control compared with Novolin 70/30-treated patients," explained Professor Bernard Böhm.

No significant difference was found in mean A1C after 24 months of treatment with NovoLog Mix 70/30 or Novolin 70/30 (8.35+/-0.20% vs. 8.13+/-0.16%, respectively).

This study showed that individuals treated with NovoLog® Mix 70/30 experienced low weight gain of 0.05 +/- 0.81 over the two-year study period compared with a 2.00 +/- 0.69 (p=0.07) in patients using biphasic human insulin. Overall frequency of adverse events was similar in the two groups.

About NovoLog® Mix 70/30

NovoLog® Mix 70/30 is indicated for the treatment of patients with diabetes mellitus for the control of hyperglycemia. Because NovoLog® Mix 70/30 has peak pharmacodynamic activity one hour after injection, it should be administered with meals. NovoLog® Mix 70/30 is contraindicated during episodes of hypoglycemia and in patients hypersensitive to NovoLog® Mix 70/30 or one of its excipients. Hypoglycemia is the most common adverse effect of insulin therapy, including NovoLog® Mix 70/30.

Any change in insulin should be made cautiously and only under medical supervision.

Full prescribing information for NovoLog® Mix 70/30 is available by contacting Novo Nordisk Inc. or visiting www.novonordisk-us.com.

Novolin and NovoLog are registered trademarks of Novo Nordisk A/S.

References

(1) Boehm, B, Vaz J, Brondsted L, Home P. Long-term efficacy and safety of biphasic insulin aspart in patients with type 2 diabetes. European Journal of Internal Medicine. 2004:15(8), 496-502.

Novo Nordisk is a healthcare company and a world leader in diabetes care. The company has the broadest diabetes product portfolio in the industry, including the most advanced products within the area of insulin delivery systems. In addition, Novo Nordisk has a leading position within areas such as hemostasis management, growth hormone therapy and hormone therapy for women. Novo Nordisk manufactures and markets pharmaceutical products and services that make a significant difference to patients, the medical profession and society. With headquarters in Denmark, Novo Nordisk employs approximately 20,000 full-time employees in 69 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 under the symbol . For U.S. information, visit www.novonordisk-us.com; for global information, visit www.novonordisk.com.

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