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| |  New Rapid-Acting Insulin Analog, NovoLog (Insulin Aspart), Now Available in U.S. PRINCETON, NJ -- September 18, 2001 -- Novo Nordisk Pharmaceuticals, Inc. today announced that NovoLog® (insulin aspart, rDNA origin) injection, the company's new rapid-acting insulin analog, is now nationally available for the treatment of diabetes. "We are pleased to make NovoLog widely available as a treatment option for people with diabetes to more easily obtain and maintain control of blood glucose levels -- which is critical in reducing the risk of long-term complications," said Martin Soeters, Company president. "Compared to regular human insulin, NovoLog acts more rapidly, allowing greater flexibility in scheduling meals and treatment, while providing good glycemic control," he added. NovoLog has faster absorption, a faster onset and shorter duration of action than regular human insulin, making it well suited for mealtime dosing to control postprandial glycemia, the rise in blood sugar following consumption of food. Regular human insulin acts more slowly so patients must usually administer it 30 minutes before eating. NovoLog has been compared to regular human insulin in three long-term, large-scale clinical trials and was shown to provide comparable glycemic control in patients with Type 1 diabetes,(1)(2) and Type 2 diabetes. NovoLog safety and tolerability was comparable to regular human insulin in all three trials. NovoLog is indicated for the treatment of adult patients with diabetes mellitus, for the control of hyperglycemia. Because it has a more rapid onset and shorter duration of action than regular human insulin, NovoLog should normally be used in regimens together with intermediate or long-acting insulin, and injection of NovoLog should immediately be followed by a meal. NovoLog is contraindicated during episodes of hypoglycemia and in patients hypersensitive to insulin aspart or one of its excipients. Hypoglycemia is the most common adverse effect of insulin therapy, including NovoLog. Made through recombinant DNA technology, NovoLog is identical to human insulin except the amino acid asparate is substituted for proline at one point in the molecule. While this modification does not change the insulin activity per unit, NovoLog has a lesser tendency to form molecular aggregates called hexamers than regular human insulin in solution; as a result, upon injection, NovoLog is absorbed more quickly and acts more rapidly and for a shorter duration. NovoLog is the first of several insulin analogs in development from Novo Nordisk. The US Food and Drug Administration approved it on June 7, 2000. Other products in development include premixed and long-acting insulin analogs. NovoLog is available in cartridges for use with the NovoPen 3, Innovo® and soon to be available InDuo® insulin delivery systems, and in vials for syringe delivery. References: (1) Raskin P, Riis A, Guthrie RA, Jovanovic L, Letter L. Use in insulin aspart, a fast-acting insulin analog, as the mealtime insulin in the management of patients with type 1 diabetes. Diabetes Care 2000; 23(5):583-588. (2) Home P, Lindholm A, Riis A. Insulin aspart vs. human insulin in the management of long-term blood glucose control in Type 1 diabetes mellitus: a randomized controlled trial. Diabetic Medicine 2000; 17:762-771. SOURCE: Novo Nordisk Pharmaceuticals, Inc.
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