Eli Lilly and partner Amylin Pharmaceuticals have caught the eye at the American Diabetes Association meeting in Chicago with data on Byetta which reveals that their new drug shows comparable blood glucose control to insulin, lowers levels of hypoglycaemia and aids weight loss.
A study of 114 people with type 2 diabetes compared treatment with Byetta (exenatide) and metformin or a sulfonylurea with insulin glargine and metformin and while blood sugar control was similar in the two arms, patients in the Byetta group had a statistically significant lower risk of hypoglycaemia (2.6%) than those in the insulin group (17.4%).
Additionally, there were seven episodes of severe hypoglycaemia in three patients taking insulin versus none on the Lilly/Amylin drug and Byetta, the first in a class of drugs called incretin mimetics, was also associated with a 5.7 pound weight loss from baseline, compared with a 1.3 pound gain among individuals in the insulin glargine group.
Lilly and Amlin also presented data which showed that treatment with Byetta was also associated with improvements in cardiovascular risk factors. The study involved 151 people with type 2 diabetes who had taken part in a 30-week placebo-controlled trial and after three and a half years, participants using Byetta injected twice-daily with oral medication enjoyed a 2%-4% drop in blood pressure, a 24% increase in high-density lipoprotein or ‘good’ cholesterol levels and a 6% decline in bad (low-density lipoprotein) cholesterol.
“The sustained improvements in blood glucose control and the secondary benefits of progressive weight loss seen with Byetta are well documented,” said David Kendall, executive director of medical affairs at Amylin, but this study which shows its “additional and important effects on cardiovascular disease risk factors” provide “interesting areas for further study”.
Byetta was approved in the USA in April 2005 and had sales of $430 million last year. The data from these studies, and getting the green light in Europe at the end of 2006, can only push that figure up.
