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Liraglutide provides significantly better glucose control than,insulin glargine in phase 3 study

COPENHAGEN, June 21, 2007-Novo Nordisk today announced clinical results from the first of five phase 3 studies with liraglutide - the once-daily human GLP-1 analogue. The 26-week study is part of the LEAD(TM) (Liraglutide Effect and Action in Diabetes) programme and included 581 patients with type 2 diabetes inadequately controlled by two of the most widely used oral antidiabetic drugs: metformin and a sulfonylurea (glimepiride). All patients in the study continued the two oral drugs and were randomised to add one daily injection of liraglutide, placebo or insulin glargine.

The average HbA1c level at the beginning of the study was between 8.0% and 8.5% and at the end of the study, more than 50% of patients in the liraglutide group had reached the American Diabetes Association goal of HbA1c < 7%. Furthermore, more than 35% achieved the American Association of Clinical Endocrinologists HbA1c target of <= 6.5%. The HbA1c reduction achieved in the liraglutide group was more than 0.2 percentage points better than in the insulin glargine group, a difference which is statistically significant.

The average weight of the patients at the beginning of the study was approximately 85 kg. At the end of the study, the difference in body weight between the liraglutide and insulin glargine treatment groups was on average 3.5 kg, statistically significant in favour of liraglutide.

Liraglutide in combination with metformin and glimepiride was well tolerated. The most frequently reported adverse event in the liraglutide arm was nausea at an absolute level of between 10 and 15%. As expected, the combination of a GLP-1 analogue with a sulfonylurea leads to some of the patients experiencing hypoglycaemia. The overall hypoglycaemia event rate in the liraglutide and insulin glargine groups was not significantly different.

Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk, said: "We are very
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