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Levemir®  (insulin detemir) in combination with NovoRapid® offer a more effective treatment option than traditional Neutral Protamine Hagedorn (NPH) insulin and human soluble insulin (HSI) in basal-bolus therapy for people with type 1 diabetes, according to the findings of a new multinational study.

The study[1], published in the latest issue of Diabetologia, showed that taking Levemir® as a basal therapy in combination with NovoRapid® as a mealtime bolus insulin controlled blood glucose levels more effectively than traditional NPH/HSI basal-bolus therapy and resulted in lower body weight.

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. Basal-bolus therapy is considered the best approach for maintaining optimal glycaemic control[2].

“Effectively controlling blood glucose over the course of a day is the goal of every insulin therapy. Basal-bolus therapy provides the best opportunity to achieve control of blood glucose², but traditionally this has been hard to maintain using conventional NPH insulin and human soluble insulin,” said the lead author of the study, Professor Kjeld Hermansen, head of Department of Endocrinology and Metabolism, University of Aarhus, Denmark. He continued: “With the new insulin analogues, we have got medications that can give people with diabetes more confidence that their condition is under control.”

Professor Hermansen added, “Insulin analogues, such as Levemir® could be the first choice over NPH insulin because of their superior control of blood glucose over many hours.” 

Study and findings

The study included 595 people with type 1 diabetes randomly assigned to basal-bolus therapy with either Levemir®/NovoRapid® or NPH/HSI. Key findings of the study include:

• Lowers HbA1c
  
Mean HbA1c was significantly lower in the Levemir®/NovoRapid® treatment group than in the NPH/HSI treatment arm after 18 weeks of treatment (7.88% versus 8.11%, respectively). HbA1c is the amount of haemoglobin with glucose attached to it, and reflects long-term glycaemic control. The average change in HbA1c from baseline to the end of treatment was a drop of 0.50% for the Levemir®/NovoRapid® group compared to a drop of 0.28% for the NPH/HSI group.


• Glucose levels are more predictable
  
The day-to-day variation in plasma glucose within a person, based on self-measurement during normal weekdays within the last week of treatment was statistically significantly lower in the Levemir®/NovoRapid® group than the NPH/HSI group.


• Hypoglycaemic episodes reduced
  
The occurrence of hypoglycaemic episodes per person-year was significantly lower in the Levemir®/NovoRapid® arm than the HPH/HSI group, both overall and during the night. The overall risk of hypoglycaemia was 21% lower in the Levemir®/NovoRapid® group, and the risk of nocturnal and major nocturnal hypoglycaemia was 55% and 83% lower, respectively, for the group taking Levemir®/NovoRapid® compared to those taking NPH/HSI.


• Reduced weight
  
A statistically significant difference in mean body weight was observed in the people with diabetes taking the analogues Levemir®/NovoRapid® in combination. After 18 weeks of treatment the mean body weight was 1.0 kg lower in the Levemir®/NovoRapid® group.

“This trial proves that insulin analogues, such as Levemir® and NovoRapid®, provide a more physiologic insulin action profile compared with conventional insulins in a basal-bolus regimen and are superior in terms of improved glycaemic control, fewer hypoglycaemic events and no weight gain,” Professor Hermansen said.

Availability

Levemir® was launched in Switzerland in March and will be made available in key European markets in the second half of 2004. It will be available in Penfill® cartridges and FlexPen®, Novo Nordisk’s prefilled insulin pen.

Notes to Editors:

• Full prescribing information for Levemir® (insulin detemir) and NovoRapid® (insulin aspart) is available by contacting the manufacturer or on www.levemir.com and www.novorapid.com
  
• Levemir® and NovoRapid® are registered trademarks of Novo Nordisk A/S.

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 18,800 people in 69 countries and markets its products in 179 countries. For further company information visit www.novonordisk.com

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References

[1] K. Hermansen, P Fontaine, K.K Kukolja, V. Peterkova, G. Leth, M-A. Gall.  Benefits of insulin analogues over human insulins: Lower HbAlc and less hypoglycaemia using insulin detemir and insulin aspart. Diabetologia 2004; Vol 47(4):622-629

[2] The Diabetes Control and Complications Trial Research Group (DCCT). The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Eng J Med 1993;329(14):977-86.