Eli Lilly Says Byetta Alone Improves Diabetics' Glucose Control, Weight Loss
Eli Lilly and Amylin Pharmaceuticals plan to ask the FDA to approve their diabetes drug Byetta, which is approved as an add-on therapy, as a monotherapy in the first half of 2008.
The companies will base their submission on a trial in which 232 drug-naive patients with Type 2 diabetes received either Byetta (exenatide) injection monotherapy twice daily or placebo. The patients who received the drug experienced improved glucose control and significant weight loss.
Participants taking 5 or 10 micrograms of monotherapy Byetta twice daily showed significant reductions in A1C, a measure of average blood sugar over three months, by 0.7 percentage points and 0.9 percentage points, respectively, from an average baseline A1C of 7.8 percent to 7.9 percent.
Approximately 60 percent of study participants on Byetta at the end of the study had an A1C of 7 percent or less, a common target for good glucose control. Weight loss from baseline was significant and similar to that observed in previous studies of Byetta, according to Eli Lilly.
The study was conducted after the sponsors received an approvable letter for a monotherapy indication from the FDA in 2005.