Phase 3 dulaglutide data positive for type 2 diabetes

Results from two recently completed phase 3 clinical trials demonstrate that a glucagon-like peptide-1 receptor agonist significantly reduced HbA1c compared with insulin glargine among patients with type 2 diabetes, according to a press release.

Dulaglutide (Eli Lilly and Company) is an investigational, once-weekly (1.5 mg), oral GLP-1 agent which has been examined in a series of studies known as the Assessment of Weekly Administration of LY2189265 in Diabetes (AWARD). The two most recent studies included over 800 patients, randomly assigning them to dulaglutide in a 52- or 78-week open-label comparison design.

The drug demonstrated significant reductions in HbA1c compared with insulin glargine at 52 weeks in patients with type 2 diabetes who were already taking metformin and glimepiride (AWARD-2), according to the release.

Furthermore, dulaglutide 1.5 mg combined with insulin lispro demonstrated statistically significant reductions in HbA1c from baseline compared with insulin glargine in combination with insulin lispro at 26 weeks (AWARD-4), according to the release.

In October 2012, the manufacturer released positive results from the three other completed phase 3 AWARD trials (AWARD-1, AWARD-3 and AWARD-5).

The full data on these findings will be presented at a future scientific meeting this year or in 2014, according to the press release. The press release also suggests that Eli Lilly and Company expects to submit dulaglutide to the FDA this year.

For more information:

Clinical Trial NCT01075282 (AWARD-2). Accessed April 16, 2013.

Clinical Trial NCT01191268 (AWARD-4). Accessed April 16, 2013.