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Novo Nordisk New Data From a Phase 3 Study Confirms Clinical Benefits of Once-Daily Liraglutide in the Management of Type 2 Diabetes
Date:9/8/2008

Paradoxically, many of the common treatment regimens for type 2 diabetes actually cause weight gain.

Treatment with liraglutide in LEAD(TM) 4 also led to a statistically significant decrease in blood pressure as seen in three of the other LEAD(TM) studies: reductions of 6.71 mmHg and 5.65 mmHg with liraglutide 1.2 mg and 1.8 mg, respectively, were observed compared to a decrease of 1.11 mmHg in the comparator group.

Beta cell function, as assessed by multiple parameters (HOMA, C-peptide and proinsulin to insulin ratio), was also significantly improved in subjects who received liraglutide versus the comparator group. Beta cell function is an important measure of disease progression in type 2 diabetes.

LEAD(TM) 4 is the last of the five phase 3a LEAD(TM) (Liraglutide Effect and Action in Diabetes) studies to be presented.

"The complete LEAD(TM) clinical trials program provides convincing evidence that liraglutide represents an effective new treatment approach for type 2 diabetes," said Dr. Bernard Zinman, Professor of Medicine, University of Toronto and Director of the Diabetes Centre Mount Sinai Hospital, Toronto, Canada. "In this clinical trial program, liraglutide offers effective glucose lowering as monotherapy or as an add on to other oral antidiabetic therapies while also consistently lowering weight and blood pressure and enhancing beta-cell function."

About the study

The LEAD(TM) 4 study was a 26-week randomized trial that compared the efficacy and safety of two different doses of liraglutide (1.2 mg and 1.8 mg, QD) to placebo, all added to metformin 2 g (1 g, BID) and rosiglitazone 8 mg (4 mg, BID). The trial included 533 subjects with a mean age of 55.1 years, mean body mass index of 33.5 kg/m2, and mean HbA1c of 8.3. All subjects were previously treated with one or more OADs and received run-in rosiglitazone and metformin therapy before being randomized to liraglutide or placebo.


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