COPENHAGEN, April 3, 2007-Newly published results in the International Journal of Clinical Practice(1) from the large-scale, observational ‘PREDICTIVE™ study’*, confirm that Levemir® for the majority of people effectively treats diabetes without causing weight gain.(1)
The PREDICTIVE™ study is examining patient outcomes when Levemir® – a long-acting modern insulin – is used in the everyday clinical setting. In the European cohort of PREDICTIVE™, a total of 20,531 people with type 1 and type 2 diabetes from 11 countries were prescribed Levemir® and followed up after 14 weeks. At this time there was not only an improvement in patients’ average blood glucose levels, but also a decrease in their average body weight. This applied to people with type 1 as well as type 2 diabetes.(1)
Professor Russell-Jones, of the Department of Diabetes and Endocrinology, Royal Surrey County Hospital, Surrey, UK, commented that: "Insulin initiation is often associated with considerable weight gain, which is a major problem for people with type 2 diabetes. Studies have shown that even a modest weight reduction can improve the cardiovascular risk profile of these people. The reduced risk of weight gain that Levemir® offers potentially provides people with diabetes an enhanced treatment option."
The risk of weight gain may act as a significant barrier to the initiation of insulin therapy or it may hinder compliance with it.(2,3) This can mean that patients remain in poor blood glucose control, which is associated with an increased risk of diabetic complications. Furthermore, increasing weight gain can in itself lead to health problems such as increasing insulin resistance, high blood pressure and raised cholesterol levels, all of which are also associated with an increased risk of cardiovascular diseases.(2,3)
On the other hand, it has been estab lished that even modest weight loss is associated with improvement in blood glucose control, insulin sensitivity and the cardiovascular risk profile.(4-9)
The unique weight benefit of Levemir® has been reported in every single clinical trial published where it has been compared to other basal insulins.(10-23) Collectively these trials provide data representing more than 4,000 patients. In two recently published randomised clinical trials that investigated insulin initiation in type 2 diabetes, mean weight gain was reduced by more than 50% when comparing Levemir® to equivalent regimens of NPH insulin.(10,11) Furthermore, the relative weight benefit of Levemir® was shown to increase with increasing body mass index (BMI).(11) Thus, the weight advantage of Levemir® tended to be more pronounced in more overweight patients.
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Levemir® is a long-acting modern insulin (insulin analogue) that covers the body’s basal insulin needs. Levemir® is released gradually from the injection site into the circulation. Compared to conventional long-acting insulins such as NPH insulin, Levemir® causes less fluctuation in blood glucose levels across the day and has greater predictability, ie a blood glucose lowering effect that is consistent from one injection to another. A single daily dose of Levemir® will provide a duration of action up to 24 hours.(24) The dose should be taken in the evening, at dinner or before bedtime. Injections can easily be managed with the simple and discreet FlexPen®, a prefilled insulin pen.(26,27)
About Novo Nordisk
Novo Nordisk is a healthcare company and a world leader in diabetes care. The company has the broadest diabetes product portfolio in the industry, including the most advanced products within the area of insulin delivery systems. In addit ion, Novo Nordisk has a leading position within areas such as haemostasis management, growth hormone therapy and hormone replacement therapy. Novo Nordisk manufactures and markets pharmaceutical products and services that make a significant difference to patients, the medical profession and society. With headquarters in Denmark, Novo Nordisk employs more than 23,600 employees in 79 countries, and markets its products in 179 countries.
*PREDICTIVE™ stands for Predictable Results and Experience in Diabetes through Intensification and Control to Target: an International Variability Evaluation. It is a large prospective, open-label, non-interventional study involving more than 30,000 juvenile and adult patients with type 1 and type 2 diabetes from 19 countries across the world. This 12-week observational study is evaluating the safety and efficacy of Levemir® (insulin detemir, Novo Nordisk) when used in routine clinical practice. The study was designed to validate the benefits and risks of Levemir® treatment seen in clinical trials, as well as to collect important information on treatment patterns and glycaemic control. PREDICTIVE™ is one of the largest observational studies ever conducted in diabetes and highlights the commitment of Novo Nordisk to enhancing treatment of diabetes and improving the quality of life of those it affects.
1 Dornhorst A et al. Safety and efficacy of insulin detemir in clinical practice: 14-week follow-up data from type 1 and type 2 diabetes patients in the PREDICTIVE European cohort. Int J Clin Pract 2007; 61(3):523–8
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