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Title: New Long-Acting Insulin, Levemir, Shows Less Weight Gain Associated With Insulin Therapy -- Now Available In Canada

"New Long-Acting Insulin, Levemir, Shows Less Weight Gain Associated With Insulin Therapy -- Now Available In Canada"

MISSISSAUGA, ON -- February 8, 2006 -- Two million Canadians with diabetes will now have access to Levemir® (insulin detemir), a new basal insulin with up to a 24 hour duration of action, to help them manage their diabetes and avoid the weight gain commonly associated with insulin therapy. Novo Nordisk Canada Inc. announced today that Levemir, a long-acting insulin analogue, is now available to treat adult Canadians with type 1 and type 2 diabetes. Studies have shown that patients treated with Levemir experienced little or no weight gain compared to other basal insulin therapy, such as NPH (Neutral Protamine Hagedorn) insulin, and offers more predictable control of blood glucose levels and reduced risk of hypoglycemia particularly during the night. "Clinical studies have shown that patients taking Levemir for type 1 or type 2 diabetes, experienced significantly less weight gain than those taking traditional human insulins and in many cases even experienced weight loss," said Dr. Robert Schlosser, Endocrinologist and Co-Director, Lifestyle Metabolism Centre, Toronto. "The flat and predictable profile of the new basal insulin Levemir may, at least in part, explain why people lose weight or do not gain as much weight on Levemir as they do on traditional human basal insulins." Weight gain: Additional concern for patients on insulin therapy In addition to the fear of daily, self injections and pain associated with insulin therapy, insulin-induced weight gain can also be problematic for people with diabetes as most often they are overweight already. Further weight gain can be substantial and occur rapidly putting them at increased risk of complications, such as adverse changes in blood pressure and lipid profiles. Study results suggest that Levemir can be used in people with type 2 diabetes without causing weight gain to the degree that typically accompanies this progression of therapy. Furthermore, recent data suggest that the more overweight a patient is before insulin therapy, the less weight they will tend to gain when taking Levemir, compared to human basal insulin. "I've been on insulin since I was four years old. When I was told that I was switching to a new, long-acting insulin, called Levemir, I was anxious to try it," says Paul May, a person living with type 1 diabetes, Toronto. "I've been taking Levemir now once-daily for four months and it has helped me to gain better control of my diabetes, including more aggressive control of blood glucose levels. I am also pleased that I've been able to maintain my weight on this insulin." In the large-scale, international UKPDS study type 2 diabetes, people beginning insulin therapy averaged a weight gain of nearly 5.2 kg (or 11.5 lbs) over the initial three years, and many gained considerably more than this. "Sometimes the thought of weight gain can often discourage people with type 2 diabetes from accepting the need for insulin, or from adhering to their prescribed therapy," says Dr. Schlosser. "These people risk developing serious complications if they allow blood glucose to remain inadequately controlled as a result of delayed or insufficient insulin therapy." In a recently published study, it was shown that patients treated with NPH insulin gained an average 3 kg (or 6.6 lbs) in weight over four months, whereas those receiving Levemir gained just 1.2 kg (or 2.6 lbs) (p < 0.05). Weight gain in patients was assessed in terms of patients' baseline body mass index (BMI), and it showed that overweight patients taking Levemir benefit from relatively less weight gain. In fact, the more overweight a person was at baseline, the less weight they would tend to gain, with clinically overweight and obese patients gaining little more than 0.5 kg (or 1.1 lbs). In contrast, patients treated with NPH insulin gained 2.6 to 3.1 kg (5.7 to 6.8 lbs) regardless of their BMI. "The prospect of moving to insulin therapy, with its attendant weight gain, can be a concern for people with type 2 diabetes," said Donna Lillie, Vice President, Research and Professional Education, Canadian Diabetes Association. "We welcome any new proven treatment that provides more options for Canadians with diabetes." Predictability and less hypoglycaemia with Levemir Levemir is a novel basal insulin analogue with a more predictable action, which should give people with diabetes the confidence that their diabetes is under control. The risk of hyperglycaemia (very high blood glucose) and hypoglycaemia (very low blood glucose) should also be reduced, and enable patients to strive for improved glycaemic control with a greater tolerance of their treatment. Predictable insulin is welcomed by doctors to make treatment targets more reachable and improve clinical outcomes. For people with diabetes, Levemir usually results in effective glycaemic control. Fasting blood glucose levels following Levemir treatment were significantly lower than those achieved with NPH insulin in individuals with type 1 diabetes in several trials. People treated with Levemir also benefited from a significantly lower incidence of episodes of hypoglycaemia, which is a concern for patients starting insulin therapy, with their overall and night-time risk being 26% less than seen with NPH insulin. About Levemir Levemir (insulin detemir) is a soluble, long-acting basal insulin analogue with a flat and predictable action profile with a prolonged duration of action. The nocturnal glucose profile is flatter and smoother with Levemir than with NPH insulin. Levemir has improved predictability of action compared to other basal preparations such as NPH insulin. This may mean that moving people with diabetes onto Levemir results in making blood sugars more predictable which might allow tighter control to be attained. Levemir has shown a weight-sparing effect compared with other basal insulin (such as NPH) when used either in type 1 or type 2 patients. Levemir is administered only in Novo Nordisk pen delivery devices which offer greater convenience, durability and reliability for people living with diabetes. Novo Nordisk insulin delivery devices have a proven track record with more than 3.5 million people using a Novolin-Pen delivery device every day, worldwide. Levemir received Health Canada approval in September 2005, and is indicated for once or twice-daily subcutaneous administration for the treatment of adult patients with type 1 or type 2 diabetes, who require a long-acting insulin for the control of high blood sugar. It is recommended for use with mealtime insulin. SOURCE: Novo Nordisk Canada Inc.

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