Novo Nordisk receives approval in the EU for use of NovoRapid® in pregnancy

Novo Nordisk announced 31th of August 2006 that the European Commission has approved the rapid-acting insulin NovoRapid (insulin aspart) for use by pregnant women with diabetes. The approvalfollows results of the largest ever randomised controlled trial of modern insulin in pregnant women with type 1 diabetes. NovoRapid is the first modern insulin that has a label stating it can be used in pregnancy in the EU.

The trial, which involved 322 pregnant women with type 1 diabetes and lasted more than four years, revealed that NovoRapid significantly improves first and third trimesters postprandial glycaemic control compared to human insulin. The risk of major hypoglycaemia was 28% lower for patients treated with NovoRapid than human insulin. Risks of major (nocturnal and diurnal) hypoglycaemia were 52% and 15% lower with NovoRapid® than for human insulin.

Source: Press-release Novo Nordisk A/S, 31.07.2006.

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