Data from three late-stage trials presented at the American Diabetes Association’s annual meeting suggest that Eli Lilly’s once-weekly type 2 diabetes therapy dulaglutide was superior to placebo and to Bristol-Myers Squibb's Byetta (exenatide), metformin and Merck & Co.’s Januvia (sitagliptin) in reducing glycosylated haemoglobin (HbA1C) levels. In addition, a greater percentage of patients treated with the higher dose of the investigational, long-acting glucagon-like peptide 1 (GLP-1) receptor agonist achieved an HbA1c goal of less than 7 percent versus all active comparators.
The AWARD clinical programme for dulaglutide includes AWARD-1, which included 978 patients with type 2 diabetes on metformin and Takeda’s Actos (pioglitazone), and was designed to determine whether dulaglutide 1.5 mg, dosed once-weekly, and Byetta was superior to placebo in reducing HbA1c from baseline at 26 weeks. The AWARD-3 trial included 807 patients with early type 2 diabetes and was designed to evaluate whether dulaglutide 1.5 mg, dosed once-weekly, is non-inferior to metformin in reducing HbA1c from baseline at 26 weeks, while AWARD-5 included 1098 patients with type 2 diabetes taking metformin and had the primary objective of determining whether dulaglutide 1.5 mg, dosed once-weekly, is non-inferior to Januvia in reducing HbA1c from baseline at 52 weeks.
Other data from the three late-stage studies found that patients taking dulaglutide 1.5 mg showed sustained weight loss for the duration of each of the trials. Specifically, patients taking dulaglutide showed significant weight loss compared to patients taking Januvia in the AWARD-5 trial and showed similar weight loss to patients taking comparators in the AWARD-1 and AWARD-3 trials. Eli Lilly noted that dulaglutide showed low rates of hypoglycaemia across these three AWARD trials and there were no cases of documented severe hypoglycaemia in any of the trials. No new safety signals were seen in any of the studies and two cases of pancreatic cancer reported among study participants were deemed highly unlikely to be connected to dulaglutide, the drugmaker added. The company expects to submit detailed data from two additional AWARD studies for presentation at scientific meetings in 2014.
"These results are a promising step forward in our effort to provide a new, once-weekly GLP-1 treatment option, giving patients another choice to help manage their diabetes," noted Sherry Martin, senior medical director of Eli Lilly Diabetes. "Dulaglutide represents an important component of our diabetes portfolio, as it could help us offer a broader range of options to patients across the diabetes spectrum," she added. The drugmaker plans to use data from the three AWARD trials to file for approval of the therapy later this year.
For further analysis on Eli Lilly’s position in the GLP-1 market space, please read ViewPoints: Can Eli Lilly muscle into GLP-1 diabetes space?
To read more Top Story articles, click here.