Eli Lilly has presented more promising late-stage data on its investigational long-acting diabetes drug dulaglutide.
The US major has presented top-line results from two Phase III studies from the five-trial AWARD programme. The first showed that dulaglutide demonstrated statistically superior reduction in HbA1c (blood sugar) levels compared to Sanofi’s Lantus (insulin glargine) at 52 weeks in patients with type 2 diabetes who were on metformin and glimeperide (AWARD-2). The second trial demonstrated that the drug, a once-weekly glucagon-like peptide 1 (GLP-1) receptor agonist, in combination with Lilly’s own Humalog (insulin lispro) was more effective than a Lantus/Humalog combo.
In October, Lilly posted impressive data from three other AWARD trials which showed that dulaglutide controlled HbA1c levels better than Byetta (exenatide), a drug Lilly helped develop before ending a collaboration with Amylin (since bought by Bristol-Myers Squibb and AstraZeneca), metformin and Merck & Co’s Januvia (sitagliptin).
Lilly stated that it expects to submit dulaglutide to regulatory authorities this year and present detailed data from the AWARD studies at scientific meetings in 2013 and 2014.
