New Data Shows That the Unique Levemir Weight Benefit Continues After Two Years of Treatment

At the same time Levemir provides significantly improved glycaemic control and reduced rates of hypoglycaemia

AMSTERDAM, Netherlands, Sept. 21, 2007-- – New data from two studies announced today by Novo Nordisk at the European Association for the Study of Diabetes (EASD) meeting confirms that Levemir® (insulin detemir [rDNA origin] injection) results in less weight gain than other basal insulins in type 1 and type 2 diabetes. The studies also demonstrate that Levemir® provides good glycaemic control in both types of diabetes and reduced rates of hypoglycaemia.1,2

In a two-year study in type 1 diabetes, patients treated with Levemir® gained significantly less weight than those on NPH insulin and at the same time had significantly improved glycaemic control compared with those on NPH insulin.1 This first long-term study with a modern basal insulin versus the older and commonly used NPH insulin demonstrates that the weight advantage of Levemir® is sustainable, while simultaneously providing significantly better glycaemic control and reduced nocturnal hypoglycaemia. 

The benefits of Levemir® are further confirmed in the large randomised clinical trial PREDICTIVE® 303, involving more than 5,000 patients. Type 2 diabetes patients who were switched from NPH insulin or insulin glargine to Levemir® over a period of 26 weeks actually lost weight, while still experiencing significant improvements in glycaemic control and reduced rates of hypoglycemia.2 

“The fact that Levemir® provides better glycaemic control, less nocturnal hypoglycaemia and less weight gain relative to NPH insulin over a period of two years is a clinical confirmation of the superior action profile of Levemir®,” commented Professor Luigi Meneghini, associate director at the Diabetes Research Institute, University of Miami Miller School of Medicine, Miami, Florida.  

“Further to the weight benefit, the data presented at EASD highlights that Levemir® is associated with significantly less weight gain in both type 1 and 2 diabetes, and that this benefit is maintained over time. Levemir® may therefore be a more acceptable basal insulin option for patients with diabetes who are concerned about treatment-associated weight gain.”

The findings on weight gain reported at EASD are consistent with the unique weight benefit associated with Levemir® observed in 13 out of 13 published clinical studies, in which it has been compared to other basal insulins such as insulin glargine and NPH insulin.3–15 Together these studies provide data on over 4,000 patients with diabetes.

An increase in weight can have an adverse effect on an individual’s cardiovascular risk profile.16,17 If a patient delays initiating insulin treatment due to fear of weight gain, glucose levels can remain uncontrolled, putting the patient at increased risk of the complications associated with diabetes. Patients with diabetes who gain weight incur significantly greater total medical care costs.18 Weight gain can also affect a patient’s psychological well-being,19 quality of life20 and persistence with their diabetes treatment regimen.21 In contrast, even modest weight loss results in substantial health benefits such as improved insulin sensitivity, decreased blood pressure and reduced overall cardiovascular risk.22,23

  About Levemir®

Levemir® is a long-acting modern insulin (insulin analogue) that covers the body’s basal insulin need.24 Levemir® is released gradually and therefore it entails less fluctuation in blood glucose levels and better predictability compared to traditional long-acting NPH insulins.24 Levemir® in combination with OADs should be initiated with once-daily administration at a dose of 10 U or 0.1–0.2 U/kg and titrated based on individual patient needs.24 The dose should be taken in the evening, at dinner or before bedtime.3 Injections can easily be managed with the trusted and simple FlexPen® prefilled insulin pen.25,26,27


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 approximately 25,350 employees in 79 countries, and markets its products in 179 countries. Novo Nordisk’s B shares are listed on the stock exchanges in Copenhagen and London. Its ADRs are listed on the New York Stock Exchange under the symbol ‘NVO’. For more information, visit novonordisk.com.

 

Further information:

Media:

Investors:

 

 

Outside North America:

Outside North America:

Katrine Sperling

Mads Veggerby Lausten

Tel: (+45) 4442 6718

Tel: (+45) 4443 7919

krsp@novonordisk.com

mlau@novonordisk.com

 

 

 

Hans Rommer

 

Tel: (+45) 4442 4765

 

hrmm@novonordisk.com

 

 

In North America:

In North America:

An Phan

Christian Qvist Frandsen

Tel: (+1) 609 987 4893

Tel: (+1) 609 919 7937

anph@novonordisk.com

cqfr@novonordisk.com

 

 

 

References

Bartley PC, et al. Superior glycaemic control, less nocturnal hypoglycaemia and less weight gain with insulin detemir relative to NPH insulin in subjects with T1DM treated for 24 months using a treat-to-target concept.  222, presented at 43rd Annual Meeting of the European Association for the Study of Diabetes, Amsterdam, 2007. Christoph Koenen, Luigi Meneghini, Wayne Weng, Jean-Louis Selam. Insulin Detemir Improves Glycaemic Control, Weight and Hypoglycaemia in Patients Previously Treated with Insulin Glargine or NPH Insulin: Results from the PREDICTIVE 303 study. Abstract 976, presented at 43rd Annual Meeting of the European Association for the Study of Diabetes, Amsterdam, 2007. 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; 28:1569–1581. 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; 29:1269–1274. 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. 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; 26:724–736. 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; 26:590–596. 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; 7:73–82. 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; 22:850–87. 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; 6:579–58. 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; 27:1081–1087. 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; 47:622–629. Rašlova K, et al. Insulin detemir and insulin aspart: a promising basal-bolus regimen for type 2 diabetes. Diabetes Res Clin Pract 2004; 66:193–201. 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; 7:56–64. Robertson K, et al. Insulin detemir compared with NPH insulin in children and adolescent with type 1 diabetes. Diabetic Medicine 2007; 24:27. Purnell JQ, et al. Effect of excessive weight gain with intensive therapy of type 1 diabetes on lipid levels and blood pressure: results from the DCCT. Diabetes Control and Complications Trial. JAMA 1998; 280:140–146. Ridderstrale M, et al. Obesity and cardiovascular risk factors in type 2 diabetes: results from the Swedish National Diabetes Register. J Intern Med 2006; 259:314–322. Elmer PJ, et al. Effects of weight gain on medical care costs. Int J Obes Relat Metab Disord 2004; 28:1365–1373. Clark M. Is weight loss a realistic goal of treatment in type 2 diabetes? The implications of restraint theory. Patient Educ Couns 2004; 53:277–283. Sundaram M, et al. EQ-5D in type 2 diabetes: relationships with quality of life and comorbid conditions. Value Health 2006; 9:A42. Nicolucci A, et al. Validation of the Italian version of the WHO-Well-Being Questionnaire (WHO-WBQ) and the WHO-Diabetes Treatment Satisfaction Questionnaire (WHO-DTSQ). Diabetes Nutr Metab 2004; 17:235–243. Williams KV, et al. Metabolic consequences of weight loss on glucose metabolism and insulin action in type 2 diabetes. Diabetes Obes Metab 2000; 2:121–129. de Leiva A. What are the benefits of moderate weight loss? Exp Clin Endocrinol Diabetes 1998; 106 (Suppl 2):10–13. Levemir®. Summary of Product Characteristics. IMS Health Worldwide Sales Data (July 2007). Niskanen L, et al. Randomized, multinational, open-label, 2-period, crossover comparison of biphasic insulin aspart 30 and biphasic insulin lispro 25 and pen devices in adult patients with type 2 diabetes mellitus. Clin Ther 2004; 26:531–40. Asakura T. Clin Ther/New Technology 2005; A2069-PO.

Posted: September 2007

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