FDA updates label of Trulicity (dulaglutide) for use in type 2 diabetes- Eli Lilly

The label for Eli Lilly once-weekly Trulicity (dulaglutide) is now updated to include use in combination with basal insulin for adults with type 2 diabetes. The U.S. Food and Drug Administration (FDA) included the changes to the approved product labeling to reflect this important information for prescribers. Trulicity is available in a prefilled pen in 0.75 and 1.5 mg doses.

The Trulicity label update is based on FDA review of results from the AWARD-9 clinical trial, a Phase IIIb, randomized, double-blind, placebo-controlled, 28-week study that evaluated the efficacy and safety of once-weekly Trulicity 1.5 mg as an add-on to titrated insulin glargine, with or without metformin, compared to placebo as an add-on to titrated insulin glargine, with or without metformin. Study results showed that Trulicity 1.5 mg significantly reduced A1C as an add-on to insulin glargine (1.4 percent) after 28 weeks compared to placebo plus insulin glargine (0.7 percent).

The label was also updated to include results from the AWARD-8 clinical trial, a Phase IIIb randomized, double-blind, placebo-controlled, 24-week study that evaluated the efficacy and safety of Trulicity 1.5 mg as an add-on to sulfonylurea compared to placebo plus sulfonylurea.