Novo Nordisk: Levemir - the New, Predictable Basal Insulin Analogue - Realising the Potential.

MUNICH, Germany -- At a Novo Nordisk symposium, 'Insulin Therapy - Realising the Potential', at the European Association of the Study of Diabetes (EASD), diabetes specialists from all around the world came together to review the extensive Levemir(R) data presented to date. The data discussed demonstrated the clinical benefits of Levemir(R) and illustrated how this new basal insulin analogue can help realise the maximum potential of insulin therapy.

Dr Malcolm Nattrass, Selly Oak Hospital, United Kingdom, who chaired the symposium said, "Bringing together all these clinical trials, clearly demonstrates that Levemir(R), in a basal-bolus regimen, is an excellent strategy for achieving the ambitious goal of nearing normoglycaemia." Chantal Mathieu from Leuven, Belgium, then added, "It is the consistent, predictable effect of Levemir(R) on blood glucose, shown in so many trials, that makes it possible to safely achieve glycaemic goals."

For the first time, 11 clinical trials, comparing Levemir(R) with NPH as a basal component of a basal-bolus regimen, were analysed together. This comprehensively showed the following clinical advantages of using Levemir(R):

--More predictability

Professor Russell-Jones presented data showing that Levemir(R) achieves more predictable pharmacodynamic profiles compared to NPH and glargine in subjects with type 1 diabetes.(1) Professor Russell-Jones then highlighted nine trials, all showing a significant reduction in blood glucose variability using Levemir(R) compared to NPH insulin indicating improved predictability for people with type 1 and type 2 diabetes.(2-10)

--Less hypoglycaemia 

Using results from 11 clinical trials comparing Levemir(R) to NPH as a basal component of basal-bolus regimen, Dr Mathieu showed the consistent risk reduction of Levemir(R) in terms of hypoglycaemia.(2-12)

--No undesirable weight gain

Professor Haring presented data from nine clinical trials comparing Levemir(R) to NPH as a basal component of a basal-bolus regimen. The results showed a significant reduction in weight gain with Levemir(R) compared to NPH. In type 1 diabetes, Levemir(R) appeared "weight neutral", while in type 2 diabetes, Levemir(R) caused less than half the amount of weight gain compared to NPH.(2-5, 8-12)

--Better glycaemic control

In the concluding remarks, Dr Malcolm Nattrass highlighted the superior glycaemic control achieved with Levemir(R) compared to conventional insulins.(8)

New data

Two new studies were also presented at the symposium. Firstly, a trial comparing Levemir(R) with NPH insulin in children and adolescents with type 1 diabetes. The results of this study showed that there is lower and more predictable fasting plasma glucose and lower risk of nocturnal hypoglycaemia with Levemir(R).(6)

A further study showed that treatment with Levemir(R) in combination with oral agents is associated with less within-subject variation in pre-breakfast and pre-dinner plasma glucose, less risk of hypoglycaemia and less weight gain compared with NPH insulin in people with type 2 diabetes.(13)

Notes to editors:

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 18,800 full-time employees in 69 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.

References:

(1) Heise T, Noesek L, Ronn BB et al. Lower within-subject variability of insulin detemir in comparison to NPH insulin and insulin glargine in people with type 1 diabetes. Diabetes 2004; Vol. 53 (6): 1614

(2) Russell-Jones D, Hermansen K, Kim H, Draeger E, et al. Significant reduction in blood glucose variability with insulin detemir versus NPH insulin: Confirmed by meta-analysis of continuous glucose monitoring. Clinical Therapeutics 2004; 26:724.

(3) Vague P, Selam J-L, Skeie S, DeLeeuw I, Elte JWF, Haahr H, Kristensen A, Draeger E. Insulin detemir is associated with more predictable glycaemic control and lower risk of hypoglycaemia compared to NPH in subjects with type 1 diabetes on a basal-bolus regimen with premeal insulin aspart. Diabetes Care 2003; 26(3):590-596.

(4) Pieber T, Grill V, Kristensen A et al. Treatment with insulin detemir allows flexible timing of administration in subjects with type 1 diabetes. Diabetes 2003; 52(Suppl 1):A130.

(5) Home P, Bartley P, Landin-Olsson M et al. Insulin detemir offers improved glycemic control compared with NPH insulin in people with type 1 diabetes. Diabetes Care 2004; 27(5):1081-1087.

(6) Robertson K et al. Benefits of insulin detemir over NPH insulin in children and adolescents with Type 1 diabetes: Lower and more predictable fasting plasma glucose and lower risk of nocturnal hypoglycaemia. Diabetes 2004; 53 (Suppl. 2): A144.

(7) Kolendorf K et al. Insulin detemir is associated with lower risk of hypoglycemia compared to NPH insulin in people with Type 1 diabetes. Diabetes 2004; 53 (Suppl. 2):A130.

(8) Hermansen K, Fontaine P, Kukolja KK 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): 622-629.

(9) Raslova et al. Diab Res Clin Pract 2004; in press.

(10) Haak T, Tiengo A, Waldhaeusel W 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, Obesity and Metabolism 2004; in press.

(11) De Leeuw I, Vague P, Selam JL 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, Obesity and Metabolism; in press.

(12) Standl et al. Diabetes Technology Ther 2004; in press.

(13) Hermansen K et al. Treatment with insulin detemir in combination with oral agents is associated with less risk of hypoglycaemia and less weight gain than NPH insulin at comparable levels of glycaemic improvement in people with Type 2 diabetes. EASD 2004 754:PS 64.

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