Novo Nordisk

Switzerland is first to launch new diabetes therapy - Levemir® (insulin detemir)

    Geneva (ots) - Novo Nordisk Switzerland announced today that Levemir® (insulin detemir), a novel, predictable basal insulin analogue with a unique mechanism of prolonging action (scientifically known as protraction), is available for people with type 1 and type 2 diabetes in Switzerland today. The Swiss launch is just the beginning of an exciting global roll-out of this novel diabetes therapy.

    Levemir® is a long-acting insulin analogue that provides more consistent day-to-day control of blood glucose levels compared to conventional insulin preparations. (1-6) Among the benefits for people with diabetes, it has been demonstrated that Levemir® reduces fasting blood glucose and the risk of hypoglycaemia, especially at night-time. (1-5) In addition, studies have shown that people using Levemir® do not experience the undesirable weight gain often associated with conventional insulin preparations. (1-5,7)

    "Our goal for the development of Levemir® was to find the best way to help people with diabetes control their glucose levels with consistent dosing," said Lars Rebien Sørensen, President and CEO of Novo Nordisk. "Levemir® completes our portfolio of insulin analogue products, and we are proud to begin the launch of this exciting product in Switzerland."

    "The development of Levemir® alongside our other diabetes therapies is testament to our commitment to treating and defeating diabetes across the world. Levemir is a result of the expertise we have built up over more than 80 years in diabetes therapies," Sørensen added.

    In order to reach as many physicians as possible on the first day of launch Novo Nordisk will supplement the existing sales force with over 100 additional Novo Nordisk employees who have received extensive training on Levemir. Today the team will be visiting 400 doctors in diabetes clinics and primary care centres, throughout Switzerland, to discuss the benefits of Levemir® over traditional therapies and to advise on best practise in insulin therapy.

    Facilitates predictable glycaemic control

    Levemir® is a basal insulin analogue that provides more predictable and consistent control of blood glucose levels (glycaemic control). As a result, blood glucose levels are maintained within a very narrow range, especially during the night. (1,3,8,9) This provides the opportunity for people with diabetes to achieve consistent dosing which facilitates optimal glycaemic control.

    The benefits of Levemir® have been confirmed in a number of     clinical studies and include:

    - A more predictable profile than NPH insulin and insulin glargine
        (6)
    - First-rate glycaemic control in basal-bolus treatment (1,3,4,8)
    - Lower risk of hypoglycaemia than NPH insulin (especially at
        night time) (1,3,8,9)
    - Better weight management in type 1 and type 2 diabetes compared
        with NPH insulin (1-5,7)
    - Has a duration of action of up to 24 hours depending on the dose
    - providing the flexibility of once- or twice-daily dosing (11)

    Benefits of Levemir® in basal-bolus regimen

    A recent study further confirmed that a basal-bolus regimen of Levemir® plus the rapid acting insulin analogue NovoRapid® provides improved and more consistent glycaemic control as well as a reduced risk of hypoglycaemia compared to a conventional regimen of NPH insulin plus short-acting human insulin. (3) Designed to mimic natural insulin release and provide a high level of glycaemic control, a basal-bolus regimen consists of bolus injections of short-acting insulin before meals to control the blood glucose surge following food consumption, and a basal injection of intermediate- or long-acting insulin to control blood glucose levels between meals and during the night.

    "The basal-bolus treatment in association with a well guided therapeutic education is an excellent strategy for achieving the ambitious goal of nearing normoglycaemia", says Dr Juan Ruiz, Endocrinologist/Diabetologist, University Hospital Lausanne, Switzerland. "The consistent, predictable effect of Levemir on blood glucose reduces the risk of hypoglycaemia, making it possible to safely achieve glycaemic goals.  We also hope to see the further benefit of less weight gain".

    Levemir® will be available in further key European countries during 2004. It will be available in Penfill cartridges and FlexPen®, the Novo Nordisk device that is simple and easy to use, providing flexibility and convenience for people with diabetes.

    Notes to editors:

    - Novo Nordisk is a focused healthcare company. Novo Nordisk holds the broadest diabetes product portfolio in the industry, including the most advanced products within the area of insulin delivery systems.

    - Novo Nordisk is a world leader in diabetes care. 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 18'000 people in 68 countries and markets its products in 179 countries. For further company information visit www.novonordisk.com

    References

    1 Home P, Bartley P, Landin-Olsson M, Russell-Jones D, Hylleberg
        B, Draeger E.  Insulin detemir offers improved glycemic control,
        less weight gain, and flexible timing of administration compared
        to NPH insulin.  Oral presentation OP 14 Insulin Therapy at the
        18th annual meeting of the International Diabetes Federation, 25
        August 2003, Paris, France.

    2 Pieber T, Grill V, Kristensen A et al. Treatment with insulin
        detemir allows flexible timing of administration in subjects
        with type 1 diabetes. Diabetologia 2003; 46(Suppl.2):A7.

    3 Hermansen K, Fontaine P, Kukolja KK et al. Benefits of Insulin
        Analogues over Human Insulins. Lower HbA1C and less
        hypoglycaemia using insulin detemir and insulin aspart.
        Diabetologia (in press).

    4 Russell-Jones D, BolinderJ, Simpson R.  Lower and more
        predictable fasting blood glucose and reduced risk of nocturnal
        hypoglycaemia with once daily insulin detemir vs. NPH in
        subjects with type 1 diabetes.  Diabetologia 2002; 45 (suppl.
        2): A51.

    5 De Leeuw I, Vague P, Selam JL, Skeie S, Elte JWF, Lang H,
        Draeger E.  Lower risk of nocturnal hypoglycaemia and favourable
        weight development in type 1 diabetic subjects after 12 months
        treatment with insulin detemir vs. NPH insulin. Diabetologia
        2002; 45 (Suppl. 2); A257.

    6 Heise T, Nosek L, Draeger E, Stender A, Rønn BB, Heinemann L,
        Kapitza C., Heinemann L.  Lower within-subject variability of
        insulin detemir in comparison to NPH insulin and insulin
        glargine in subjects with type 1 diabetes.  Oral presentation OP
        12 Insulin Therapy at the 18th annual meeting of the
        International Diabetes Federation, 25 August 2003, Paris,
        France.

    7 Haak T, Tiengo A, Waldhausl W, Draeger E. Treatment with insulin
        detemir is associated with predictable fasting blood glucose
        levels and favourable weight development in subjects with type 2
        diabetes. Diabetes Care 2003, 52 (Suppl 1): A120.

    8 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;26:590-596.

    9 Roberts A, Bayer T, Munksgaard E, Lang H, Standl E.  Efficacy
        and safety of 6- month treatment with insulin detemir in type 1
        diabetic patients on a basal/bolus regimen.  Diabetologia
        2001;44 (Suppl 1):A207.and Diabetes 2001;50(2):A129.

    10 Hermansen K, Madsbad S, Perrild H, Kristensen A, Axelsen M.
         Comparison of the soluble basal insulin analogue insulin
         detemir with NPH insulin. Diabetes Care 2001,VOL. 24: 296-301.

    11 Pieber TR, Plank J, Goerzer E, Sommer R, Wutte A, Sinner F,
         Bodenlenz M, Endahl L, Draeger E, Zdravkovic M. Duration of
         action, pharmacodynamic profile and between-subject variability
         of insulin detemir in subjects with type 1 diabetes.
         Diabetologia 2002;45 (Suppl.2); A257.

ots Originaltext: Novo Nordisk
Internet: www.newsaktuell.ch

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