The primary endpoint was change in HbA1c over 26 weeks. Both doses of dulaglutide proved superior to metformin, with reductions of 0.78% with dulaglutide at 1.5 mg and 0.71% at 0.75 mg, compared with 0.56% with metformin, reported Dr. Umpierrez, professor of medicine at Emory University and chief of diabetes and endocrinology at Grady Memorial Hospital, Atlanta.
Session chair Dr. Julio Rosenstock didn’t buy Dr. Umpierrez’ conclusion that AWARD-3 proved dulaglutide to be superior to metformin. He argued that even if the differences in HbA1c reduction between the dulaglutide- and metformin-treated patients were statistically significant, they were too small to be clinically meaningful. "I don’t think this is clinical superiority. You’ve presented evidence that dulaglutide is comparable in efficacy to metformin in early type 2 diabetes. I see it as an option for patients who can’t tolerate metformin," commented Dr. Rosenstock, director of the Dallas Diabetes and Endocrine Center.
The AWARD trials were supported by Eli Lilly, which anticipates applying to the Food and Drug Administration for marketing approval of dulaglutide before the end of the year. All three presenters reported receiving research grants from Eli Lilly and other pharmaceutical companies. Drs. Wysham and Nauck are also on the Eli Lilly advisory board.