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www.fdanews.com/articles/89466-novo-nordisk-s-levemir-approved-in-europe-for-combination-use

NOVO NORDISK'S LEVEMIR APPROVED IN EUROPE FOR COMBINATION USE

March 6, 2007

Novo Nordisk announced that the European Commission has approved Levemir for once-daily use in combination with oral diabetic drugs. The approval provides a new treatment option for people with Type 2 diabetes who have difficulties in maintaining acceptable blood glucose levels when treated with oral diabetic drugs alone, according to the company.

Levemir (insulin detemir) administered once daily significantly improves blood glucose levels, with less associated weight gain compared with neutral protamine hagedorn (NPH) insulin and insulin glargine. Levemir is the first long-acting insulin associated with less weight gain, and the weight benefit of Levemir has been shown to increase with increasing baseline body mass index.

"Our findings showed that not only did Levemir given once daily improve glycaemic control, but unlike many other forms of insulin, it actually led to weight loss and this benefit was even greater for the more obese people with diabetes," Anne Dornhorst, leading investigator for the PREDICTIVE study, said.

Furthermore, Levemir provides effective blood glucose control with a reduced risk of hypoglycaemia. A recent trial shows that Levemir reduces the relative overall risk of hypoglycaemia by 53, while the relative risk of nocturnal hypoglycaemic events was reduced by 65 percent compared with NPH insulin, according to the company.

Levemir is a long-acting modern insulin that covers the body's basal insulin need. It is released gradually, and therefore it entails less fluctuation in blood glucose levels and is more predictable compared with traditional long-acting NPH insulins. Levemir delivers up to 24 hours of action with a single daily dose.