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A novel, weekly glucagon-like peptide-1 (GLP-1) agonist met pre-specified endpoints for non-inferiority and also proved superior to insulin glargine (Lantus) at lowering glycated hemoglobin (HbA1c) in patients with type 2 diabetes, according to a release from drugmaker Eli Lilly.
In two phase III trials in the AWARD series, once-weekly injections of 1.5 mg of dulaglutide hit the primary efficacy endpoint of non-inferiority to insulin glargine in controlling HbA1c, although specific numerical data were not reported in the company release.
Given the achievement of non-inferiority, the researchers also looked at dulaglutide's superiority against glargine.
In AWARD-2, dulaglutide was statistically superior to glargine at lowering HbA1c over 52 weeks in type 2 diabetes patients already taking metformin and glimepiride.
In AWARD-4, the novel GLP-1, in combination with short-acting insulin lispro (Humalog), was statistically superior to glargine plus lispro at lowering HbA1c over 26 weeks compared with glargine.
Again, however, specific numerical data were not reported.
Eli Lilly previously released positive top-line data from three other phase III AWARD Trials (1, 3, and 5) in October, and the company said it plans to submit the data for regulatory approval this year.
Lilly relinquished its rights to another GLP-1 agonist, exenatide (Byetta), in fall 2011 when its partnership with San Diego-based Amylin pharmaceuticals was dissolved.
Amylin accused Eli Lilly of a contract violation when it partnered with another drug company, Boehringer Ingelheim, on a potential rival diabetes drug.
The weekly form of exenatide (Bydureon) was approved in January 2012.