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| | Novo Nordisk Prevails in Sanofi-Aventis Challenge to Levemir® |
| date: Jul 4th 2006 11:49 page: 1 | 2
Levemir is widely available in over 44,000 pharmacies throughout the United States. Levemir is currently approved in 50 countries worldwide. With the introduction of Levemir, Novo Nordisk is the only company to provide a complete portfolio of insulin analogs.
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 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.

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