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Published on 9 June 2009

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Results from LEAD 6 study published online

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Today, The Lancet published online the results of the LEAD 6 study, a direct comparison between two products in a new class of diabetes treatments, the GLP-1 receptor agonists.

Results show that patients treated with liraglutide had a statistically greater drop in HbA1c than those who received exenatide.

The study compared liraglutide, a human GLP-1 analogue, which is under investigation as a treatment for type 2 diabetes, to exenatide, the currently marketed GLP-1 receptor agonist.

“Because of the differences in how the body absorbs and eliminates these two compounds, we were very interested to see if there were clinically meaningful differences in the effect in people with diabetes,” said Dr John Buse, chief of endocrinology and director of the Diabetes Care Center at the University of North Carolina School of Medicine, and one of the principal investigators in the study.

“The clinical benefits that liraglutide provides – from greater glucose lowering to weight loss to better tolerability and improvements in beta-cell function – represent a clinically meaningful treatment advance for patients with type 2 diabetes.”

LEAD 6 was a randomised, open-label study comparing the efficacy and safety of liraglutide 1.8 mg, once a day, to exenatide 10 µg, twice a day.

Treatment with liraglutide led to a statistically significantly greater drop in HbA1c of 1.12% compared to 0.79% in the exenatide group, and liraglutide was also significantly better than exenatide at lowering fasting plasma glucose (–1·61 mmol/L vs –0·60 mmol/L) in this typical type 2 diabetes population.

The study comprised 464 patients who were not reaching recommended blood sugar targets on either the maximally tolerated doses of metformin, sulphonylurea, or both, which are standard oral antidiabetic medications currently available.

Both treatments led to a weight reduction of on average 3 kg during the 26-week study. Nausea was the most commonly reported adverse event with both treatments but the study results showed that there was less persistent nausea and fewer minor hypoglycaemic events with liraglutide compared to exenatide.

The most common adverse events reported in both groups were diarrhoea, indigestion, nausea, common cold and headache.



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