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news.Eli Lilly and Company's two additional Phase III Assessment of Weekly AdministRation of LY2189265 in Diabetes (AWARD) trials of dulaglutide in type 2 diabetes have met primary efficacy endpoints.
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The primary efficacy endpoints of both the AWARD-2 and AWARD-4 studies were non-inferiority to insulin glargine, as measured by the reduction of hemoglobin A1c (HbA1c) levels at the 1.5mg dose.
Lilly Diabetes president Enrique Conterno said the company’s efforts to offer a broad portfolio of therapies for people with diabetes will be advanced if dulaglutide wins approval.
"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," Conterno added.
Dulaglutide 1.5mg dose acheived statistically superior reduction in HbA1c from baseline compared to insulin glargine at 52 weeks in type 2 diabetes patients on metformin and glimeperide in the AWARD-2 study.
In the AWARD-4 study, dulaglutide 1.5mg dose in combination with insulin lispro acheived statistically superior reduction in HbA1c from baseline compared to insulin glargine in combination with insulin lispro at 26 weeks.
Most frequently reported gastrointestinal-related adverse events were consistent with prior dulaglutide studies.