Data presented today at the European Association for the Study of Diabetes (EASD) annual congress in Copenhagen, Denmark, show that treatment with Levemir® (insulin detemir) and NovoRapid® (insulin aspart) improves metabolic control and at the same time reduces the rate of hypoglycaemia quite dramatically in people with type 1 diabetes without causing undesirable weight gain.[1]. No other basal–bolus therapy currently available shows the combined
advantages demonstrated by these data. [2,3]
Dr Anne Dornhorst from Imperial College, London, England, said: "Weight gain can have serious consequences for people with diabetes and effective management of diabetes with insulin therapy can often be a cause of increased body weight. These results show that the use of this basal–bolus regimen is providing excellent disease management whilst not causing undesirable weight gain."
The results are based on data from 179 people with type 1 diabetes from a sub-group of the German arm of the PREDICTIVE™ study1, one of the largest global observational studies ever conducted in diabetes. These results show that patients switching from human insulin basal–bolus therapy to a Levemir® and NovoRapid® basal–bolus regimen benefited from [1]:
· improved glycaemic control
· reduction in the rate of overall hypoglycaemia
· reduction in the rate of nocturnal hypoglycaemia
· no weight gain.
These findings further support data presented at the American Diabetes Association (ADA) congress earlier this year from over 10,000 patients in the German arm of the PREDICTIVE™ study. These results demonstrated that Page 2 of 4 Novo Nordisk A/S Novo Allé Telephone: Internet: CVR Number: Corporate Communications 2880 Bagsværd +45 4444 8888 novonordisk.com 24256790 Denmark Telefax: +45 4444 2314 Levemir® improved glycaemic control and reduced the risk of hypoglycaemia in people with type 1 and type 2 diabetes without causing weight gain. [4]
Further data, also presented at EASD, confirm the once-daily action of
Levemir®.5 These data are from the first head-to-head study of the time-action profiles of Levemir® (insulin detemir) and insulin glargine in patients with type 2 diabetes. The study concluded that there were no substantial differences in the shape of the profiles, duration of action and dose-response relationship between both insulins.
Why is preventing weight gain important for people with diabetes?
Weight gain is a common problem with insulin therapy, weight gain in people with type 1 diabetes can be substantial.6 The consequences of weight gain in particular for people with type 2 diabetes are considerable.[7] Weight gain, especially central obesity (visceral fat), may increase insulin resistance, which is associated with hypertension and dyslipidaemia (increased cholesterol levels), and hence increased risk of cardiovascular disease.
In addition, the fear of putting on weight can result in patients not wanting to start insulin treatment and reduce patient compliance.
References:
1. Ackermann RW, Hansen JB, Nauck M. Basal–bolus therapy with insulin detemir/insulin aspart improves glycaemic control and reduces hypoglycaemia: data from the German cohort of the PREDICTIVETM study. European Association of the Study of Diabetes congress, 2006. Poster number 978.
2. Haak T, Tiengo A, Waldhäusel 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. 2005 Jan; 7(1):56–64.
3. Hermansen K, Fontaine P, Kukolja 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.
4. Lüddeke HJ, Hansen JB, Nauck M. PREDICTIVETM: A global, prospective, observational study to evaluate insulin detemir treatment in type 1 and type 2 diabetes: German cohort data. American Diabetes
Association: 66th Annual Scientific Sessions, 2006, Washington, US. Poster 511-P.
5. Heise T, Klein O, Lynge L et al. Insulin detemir and insulin glargine similar time-action profiles in subjects with type 2 diabetes. European Association for the Study of Diabetes congress, 2006. Oral resentation
146.
Page 3 of 4
Novo Nordisk A/S Novo Allé Telephone: Internet: CVR Number:
Corporate Communications 2880 Bagsværd +45 4444 8888 novonordisk.com 24256790
Denmark Telefax:
+45 4444 2314
6. The DCCT Research Group. Weight gain associated with intensive therapy in the Diabetes Control and Complications Trial. Diabetes Care 1998; 11:567–573.
7. Dr Nishan Wijenaike. Insulin Treatment and Weight Gain. The West Suffolk Diabetes Service; Nov 2004:
(http://www.diabetesuffolk.com/Living%20with%20Diabetes/Insulin%20treatment%20and%20weight%
20gain.asp).
8. Levemir® Summary of Product Characteristics
Notes to editors
About the PREDICTIVE™ study
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.
PREDICTIVE™ stands for Predictable Results and Experience in Diabetes through Intensification and Control to Target: an International Variability Evaluation. It is a large prospective, openlabel, non-interventional study involving more than 35,000 juvenile and adult patients with type 1 and type 2 diabetes from over 20 countries across the world. All countries collect data at
baseline and after 12 weeks. Some countries also collect data at later time points, up to three years from the first visit.
PREDICTIVE™ evaluates the safety and efficacy of Levemir® (insulin detemir, Novo Nordisk) when used in routine clinical practice. The study aims to validate the benefits of Levemir® treatment seen in clinical trials, as well as collect important information on treatment patterns and glycaemic control. The observational data is augmented by data from approximately 8,000 patients who participate in interventional variants of PREDICTIVE™; these are conducted along
the principles of controlled clinical trials, including Good Clinical Practice (GCP).
Data were compared between baseline and three months from 179 patients in the German cohort of the PREDICTIVE™ study, who switched from NPH insulin/human soluble insulin to insulin
detemir/insulin aspart.
Switching basal–bolus therapy to insulin detemir/insulin aspart was associated with a marked reduction in the rate of overall hypoglycaemia: the proportion of patients reporting all hypoglycaemic episodes fell to 23% from 59% on switching to the all analogue regimen, while the proportion of patients experiencing nocturnal hypoglycaemia was reduced from 39% to 8%.
Switching to all analogue basal–bolus therapy was also associated with improved glycaemic control: HbA1c was reduced by 0.65% from pre-study values to 7.45%; fasting blood glucose (FBG) was reduced by 39.4 mg/dl. Within-subject FBG variability was also reduced by 13.4
mg/dl. Throughout the observation period, body weight remained stable and unchanged.
About basal–bolus regimens
A basal–bolus regimen consists of a long-acting insulin to cover the body's constant basal insulin need and a rapid-acting insulin to control the 'spike' in blood sugar following a meal.
About Levemir®
Levemir® is a long-acting modern insulin (insulin analogue) that covers the body's basal insulin need. The time-action profile of Levemir® is less variable and therefore more predictable than for
Page 4 of 4 Novo Nordisk A/S Novo Allé Telephone: Internet: CVR Number:
Corporate Communications 2880 Bagsværd +45 4444 8888 novonordisk.com 24256790
Denmark Telefax:
+45 4444 2314
NPH insulin.7 Levemir® can be used once daily and has a duration of action of up to 24 hours.5
Unlike other insulins, Levemir® is not associated with undesirable weight gain.1
About NovoRapid®
NovoRapid® is a rapid-acting modern insulin, approved for the treatment of type 1 and type 2 diabetes in patients over two years old in Europe. NovoRapid® has been developed for use immediately before or soon after a meal and is normally used in a basal–bolus combination regimen with long-acting insulin, such as Levemir®, and was recently approved in pregnancy.
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 22,750 employees in 79 countries, and markets its
products in 179 countries.
For further information please contact:
Media: Investors:
Katrine Sperling Mogens Thorsager Jensen
Tel: (+45) 3079 6718 Tel: (+45) 4442 7945
Michael Laub
Tel: (+45) 3079 1960
