NovoRapid, the rapid-acting insulin from Novo Nordisk, has received European Commission's approval for safe usage by pregnant women with diabetes, claiming as the first modern insulin to come up with a label endorsing its usage in pregnancy.

The company informed that a four year study on 322 pregnant women with type one diabetes in over 90 centres from 17 countries across the world has proved significant improvement in first and third trimesters postprandial glycaemia control when compared to human insulin. The product received approval from the European Commission to endorse safe usage in pregnant women, by the end of July 2006.

NovoRapid (aspart) has been prevalent in the market for the last two years as an insulin drug for generally affected diabetes patients and the new approval adds a specific qualification on the product for usage in Gestational Diabetes Mellitus (GDM), the company officials added in a press conference.

The product has already been recognized as short acting analogue, which results in rapid secretion of insulin as meal related peak, synthesized by means of rDNA technology and can be applied five minutes before meals or even as a post meal induction, according to Dr Anil Shinde, Medical Director, Novo Nordisk India Pvt. Ltd.

"In the next two to three decades around 80 million women in the reproductive age is expected to suffer GDM and around 20 million of these will be Indian women. According to studies, the risk of developing glucose deficient disease in Indian women is increasing in a rate of 11 fold, which makes the situation more worse," told Dr V Sheshiah, Chairman, Dr V Sheshiah Diabetes Care and Research Institute, Chennai who has participated in the trials of NovoRapid. He said that approximately seven percent of all pregnancies are complicated with GDM and the new finding on the modern insulin would be safe and effective option for the pregnant women with diabetes.