Eli Lilly and Company has reported positive top-line results from two additional Phase III Assessment of Weekly Administration of LY2189265 in Diabetes (AWARD) trials of dulaglutide in type 2 diabetes.
Dulaglutide is an investigational, long-acting glucagon-like peptide 1 (GLP-1) receptor agonist being studied as a once-weekly treatment for type 2 diabetes.
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.
Both the AWARD-2 and AWARD-4 studies met primary efficacy endpoints of non-inferiority to insulin glargine, as measured by the reduction of hemoglobin A1c (HbA1c) levels at the 1.5mg dose.
Subsequently, the studies examined the superiority for HbA1c lowering.
The dulaglutide 1.5mg dose demonstrated statistically superior reduction in HbA1c from baseline compared to insulin glargine at 52 weeks in patients with type 2 diabetes on metformin and glimeperide in the AWARD-2 study.
The dulaglutide 1.5mg dose in combination with insulin lispro demonstrated statistically superior reduction in HbA1c from baseline compared to insulin glargine in combination with insulin lispro at 26 weeks in the AWARD-4 study.
Most frequently reported gastrointestinal-related adverse events were consistent with prior dulaglutide studies.
In October 2012, Lilly announced that the other three Phase III AWARD trials AWARD-1, AWARD-3 and AWARD-5 met primary efficacy endpoints.
The company anticipates submitting dulaglutide to regulatory authorities in 2013.
Image: Eli Lilly additional AWARD trials of dulaglutide examined efficacy compared to insulin glargine. Photo: Guanaco152003.