Novo Nordisk received the approval from the European Commission for the rapid-acting insulin NovoRapid (insulin aspart) for use by pregnant women with diabetes. The approval follows results of the largest ever-randomised controlled trial of modern insulin in pregnant women with Type 1diabetes.
Which involved 322 pregnant women with Type 1 diabetes, which lasted for more than four years, revealed that NovoRapid significantly improved first and third trimesters postprandial glycaemic control as compared to human insulin. The risk of major hypoglycaemia was 28 per cent lower for patients treated with NovoRapid than human insulin. Risks of major (nocturnal and diurnal) hypoglycaemia were 52 per cent and 15 per cent lower with NovoRapid than for human insulin, said a company release.
Diabetes presents a significant problem for many women wishing to conceive. The pregnancy outcomes for women with diabetes have been poor. Population studies show that babies of women with Type 1 diabetes continue to have a significantly higher risk of perinatal death and congenital anomalies than the general population.
Novo Nordisk, a world leader in diabetes care, has the broadest product portfolio including the most advanced drugs within the area of insulin delivery systems. The company also has a leading position in haemostasis management, growth hormone therapy and hormone replacement therapy.