said Sunday their injectable drug Byetta achieves the sameblood-sugar control as insulin while cutting the risk of a sharp drop inblood sugar.
Results of a Lilly-sponsored clinical trial said combining Byetta withthe generic diabetes pill metformin produced a statistically significantreduced risk of hypoglycemia, or low blood sugar, vs. a treatment of insulinand metformin.
Among 114 patients tested, 2.6% in the Byetta group suffered fromhypoglycemia, vs. 17.4% in the insulin group. The difference is statistically significant. There was no difference between Byetta patients and insulin patients who both took another generic diabetes pill called sulfonylurea. Patients' progress was measured over two 16-week periods.
The test results, presented at the American Diabetes Association annualscientific meeting in Chicago, looked at patients with Type 2 diabetes, inwhich the body can't make enough insulin or can't process insulinadequately. Insulin helps the body convert sugar into energy. Type 2patients often take more than one drug to control blood sugar.
The companies said the Byetta group lost an average of 5.7 pounds whilethe insulin group gained an average of 1.3 pounds, but the companies didn'tsay whether the difference was statistically significant. Byetta, which is injected twice a day, was approved by the Food and Drug Administration in 2005. It is prescribed as an additional therapy for Type 2 diabetics who have trouble controlling theirblood-sugar levels with certain oral medications.
The Lilly-Amylin announcement comes three days after
said its experimental drug liraglutide
produced statistically significantreductions in blood sugar vs. people taking insulin. The Novo Nordisk druggroup also achieved a statistically significant lower weight than theinsulin group.
Liraglutide acts in a similar fashion to Byetta. Analysts view it asByetta's closest competitor in a class of drugs that are analogues of anatural protein that stimulates insulin production. Novo Nordisk hopes toseek U.S. and European Union approval in mid-2008.
Like the Byetta study, Novo Nordisk compared users of its drug plusthe oral drugs metformin or sulfonylurea vs. users of insulin who also tookone of the oral drugs. And like the Byetta test, the Novo Nordisk drug wasmatched against a type of insulin called Lantus from