Novo Nordisk has “first” modern insulin approved for pregnancy

Novo Nordisk, the insulin analogues manufacturer, has announced it has received approval from the European Commission for the use of NovoRapid, a fast-acting insulin aspart, in pregnant patients.

The company describes NovoRapid as the first modern insulin to be given a label for treating pregnant women in Europe – a decision made by the European Commission following the results of the “largest ever” trial of a modern insulin in pregnant women with type one diabetes, involving 322 patients.

Some of the treatment benefits demonstrated during the trial included fewer pre-term deliveries, reduced risks to the foetus comparable with the use of human insulin, as well as “consistently” lower rates of major hypoglycaemia – a reduction of 28 per cent over human insulin.

A statement from the Danish company read: “Diabetes presents a significant problem for many women wishing to conceive.”

“Historically, pregnancy outcomes for women with diabetes have been poor. Population studies show that babies of women with type one diabetes continue to have a significantly higher risk of perinatal death and congenital anomalies than the general population.”

Diabetes UK, the diabetes charity, says that pregnant women with diabetes should check their blood glucose levels at least four times a day, stop smoking or drinking alcohol and keep to exercise regimes.

In some cases, women can develop gestational diabetes mellitus – a type of diabetes that occurs only during pregnancy in some women, caused when insulin production cannot meet the increased demands of a pregnant body. Gestational diabetes most commonly comes to light during the second trimester of pregnancy.

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