New Data Confirm That Use of Levemir Can Limit Weight Gain
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 established 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 addition, 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
2 Fritsche A, Häring H. At last a weight neutral insulin? Int J Obes Relat Metab Disord 2004; 28 Suppl 2:S41–6
3 Russell-Jones D, Khan R. Insulin-associated weight gain in diabetes – causes, effects and coping strategies. Diabetes, Obesity & Metabolism. DOI: 10.1111/j.1463-1326.2006.00686.x
4 Golay A et al. Effects of weight loss on glucose disposal in obese and obese diabetic patients. Int J Obes 1985; 9:181–91
5 Williams KV, Kelley De. Metabolic consequences of weight loss on glucose metabolism and insulin action in type 2 diabetes. Diabetes Obes Metab 2000; 2:121–29
6 Wing RR et al. Long-term effects of modest weight loss in type II diabetic patients. Arch Intern Med 1987; 147:1749–53
7 de Leiva A. What are the benefits of moderate weight loss? Exp Clin Endocrinol Diabetes 1998; 106:10–13
8 Case CC et al. Impact of weight loss on the metabolic syndrome. Diabetes Obes Metab 2002; 4:407–14
9 Krebs JD et al. Changes in risk factors for cardiovascular disease with body fat loss in obese woman. Diabetes Obes Metab 2002; 4:379–87
10 Philis-Tsimikas A et al. Comparison of once-daily insulin detemir with NPH insulin added to a regimen of oral antidiabetic drugs in poorly controlled type 2 diabetes. Clin Ther 2006; 28(10):1569–81
11 Hermansen K et al. A 26-week, randomized, parallel, treat-to-target trial comparing insulin detemir with NPH insulin as add on therapy to oral glucose-lowering drugs in insulin-naive people with type 2 diabetes. Diabetes Care 2006; 29(6):1269–74
12 Rosenstock J et al. Insulin Detemir Added to Oral Anti-Diabetic Drugs in Type 2 Diabetes Provides Glycemic Control Comparable to Insulin Glargine with Less Weight Gain. Diabetes 2006; 55:A132
13 Russell-Jones D et al. Effects of QD insulin detemir or neutral protamine Hagedorn on blood glucose control in patients with type 1 diabetes mellitus using a basal-bolus regimen. Clin Ther 2004; 26(5):724–36
14 Vague P et al. Insulin detemir is associated with more predictable glycaemic control and reduced risk of hypoglycaemia than NPH insulin in patients with type 1 diabetes on a basal bolus regimen with premeal insulin aspart. Diabetes Care 2003; 26(3):590–96
15 De Leeuw I et al. Insulin detemir used in basal-bolus therapy in people with type 1 diabetes is associated with a lower risk of nocturnal hypoglycaemia and less weight gain over 12 months in comparison to NPH insulin. Diabetes Obes Metab 2005; 7(1):73–82
16 Pieber T et al. Comparison of three multiple injection regimens for Type 1 diabetes: morning plus dinner or bedtime administration of insulin detemir vs. morning plus bedtime NPH insulin. Diabetic Medicine 2005; 22(7):850–57
17 Standl E et al. The 12-month efficacy and safety of insulin detemir and NPH insulin in basal-bolus therapy for the treatment of type 1 diabetes. Diabetes Technology Therapeutics 2004; 6(5):579–88
18 Home P et al. Insulin detemir offers improved glycemic control compared with NPH insulin in people with type 1 diabetes: a randomized clinical trial. Diabetes Care 2004; 27(5):1081–87
19 Hermansen K et al. Insulin analogues (insulin detemir and insulin aspart) versus traditional human insulins (NPH insulin and regular human insulin) in basal bolus therapy for patients with type 1 diabetes. Diabetologia 2004; 47(4):622–29
20 Rašlova K et al. Insulin detemir and insulin aspart: a promising basal-bolus regimen for type 2 diabetes. Diabetes Res Clin Pract 2004; 66(2):193–201
21 Haak T et al. Lower within-subject variability of fasting blood glucose and reduced weight gain with insulin detemir compared to NPH insulin in patients with type 2 diabetes. Diabetes Obes Metab 2005; 7(1):56–64
22 Robertson K et al. Insulin detemir compared with NPH insulin in children and adolescent with type 1 diabetes, Diabetes Medicine 2007; 24(1):27
23 Pieber TR et al. Insulin detemir plus insulin aspart is associated with less risk of major as well as nocturnal hypoglycaemia than insulin glargine plus insulin aspart at comparable levels of glycaemic control in type 1 diabetes. Diabetic Medicine 2007. In press.
24 Klein O et al. Albumin-bound basal insulin analogues (insulin detemir and NN344): Comparable time-action profiles but less variability than insulin glargine in type 2 diabetes. Diabetes Obesity Metab. DOI: 10.1111/j.1463-1326-2006.00685.x
25 Lawton S. Diabetes 2001; 50 Suppl 2: A440
26 Asakura T. Clin Ther/New Technology 2005; A2069-PO
Posted: April 2007
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