Eli Lilly has announced positive top-line results for two of its Phase III trials, AWARD-2 and AWARD-4, which evaluated dulaglutide as a once-weekly treatment in patients with type 2 diabetes. Both trials met the primary efficacy endpoints, demonstrating non-inferiority of dulaglutide compared to insulin glargine, measured by a reduction of hemoglobin A1c (HbA1c) levels at the 1.5 mg dose level.
Superiority for HbA1c lowering was also investigated. At week 52, patients receiving dulaglutide 1.5 mg showed statistically superior reduction in HbA1c from baseline compared with those on insulin glargine (AWARD-2). Dulaglutide 1.5 mg dose in combination with insulin lispro was also found to be statistically superior in reducing HbA1c from baseline at week 26 compared with insulin glargine plus insulin lispro (AWARD-4).
The most commonly reported adverse events were gastrointestinal-related, consistent with finding from previous studies of dulaglutide.
Dulaglutide is a long-acting glucagon-like peptide 1 (GLP-1) receptor agonist being developed for the treatment of type 2 diabetes. Positive top-line results were reported in October 2012 for other completed AWARD (Assessment of Weekly AdministRation of LY2189265 in Diabetes) Phase III trials—AWARD-1, AWARD-3 and AWARD-5. All three trials met the primary efficacy endpoints (i.e., reduction in HbA1c following treatment with dulaglutide 1.5 mg). The five AWARD studies (1-5) will support regulatory filings of dulaglutide.
"Dulaglutide, if approved, further advances our efforts to offer a broad portfolio of therapies for people with diabetes, many of whom have unique needs," said Enrique Conterno, president of Lilly Diabetes in a press release. "The results of our Phase III dulaglutide trials are encouraging and we look forward to sharing more details on the AWARD studies at upcoming scientific meetings."
Detailed data from the AWARD studies will be presented at scientific meetings in 2013 and 2014. The company expects to submit regulatory filings for dulaglutide in 2013.