'Good News' From the FDA: Label Changes for Dulaglutide, Canagliflozin

This transcript has been edited for clarity.

Today I'm going to discuss two label changes from the FDA: one for dulaglutide and one for canagliflozin.

Higher Doses of Dulaglutide

The dulaglutide label change allows for two higher doses to be used in the treatment of type 2 diabetes. The data for this change came from the AWARD-11 trial, which was a phase 3, randomized controlled trial involving 1842 participants with type 2 diabetes. They compared the safety and efficacy of two new doses of dulaglutide, 3 mg and 4.5 mg, with 1.5 mg, which is the dose we traditionally use.

The data showed an increased reduction in A1c and more weight loss with the higher doses. At 1.5 mg weekly, there was a 1.5% reduction in A1c and a 6.8-lb weight loss. In the 3-mg group, there was a 1.7% reduction in A1c and a weight loss of 8.8 lb. In the 4.5-mg dose group, there was a 1.9% reduction in A1c and a weight loss of 10.4 lb.

This was not associated with an increased risk for side effects, but I suggest going up slowly to help patients avoid getting the GI side effects that we see with these agents.