FDA Updates Dulaglutide Label for the Treatment of Type 2 Diabetes

The FDA has updated the label of dulaglutide (Trulicity) to include use in combination with basal insulin for adults with type 2 diabetes (T2D), according to an Eli Lilly press release.

Dulaglutide is a once-weekly glucagon-like peptide-1 receptor injectable prescription drug designed to improve glucose in adults with T2D.

The drug is now available in a prefilled pen in 0.75- and 1.5-mg doses, and should be used in conjunction with diet and exercise, according to the release.

“Despite best efforts to manage their A1C, many adults with type 2 diabetes may need to add to or change their treatment plans to help them reach their blood sugar goals,” Sherry Martin, MD, vice president of Global Medical Affairs at Lilly Diabetes, said in the company release. “They now have the option to use Trulicity, with its powerful efficacy in a once-weekly, easy-to-use pen, along with basal insulin for even greater control.”

The label update is based on an FDA review of results from the 28-week AWARD-9 clinical trial, according to the release. The double-blind, placebo-controlled, randomized phase 3b study evaluated the safety and efficacy of once-weekly dulaglutide 1.5 mg as an add-on to titrated insulin glargine, with or without metformin, compared with placebo as an add-on to titrated insulin glargine, with or without metformin.

The results of the study showed that 1.5-mg dulaglutide significantly reduced A1C as an add-on to insulin glargine (1.4%) after 28 weeks, compared with placebo plus insulin glargine (0.7%).

Additionally, the label was updated to include results from the randomized, double-blind, placebo-controlled, phase 3b AWARD-8 clinical trial. The 24-week study evaluated the safety and efficacy of dulaglutide 1.5 mg as an add-on to sulfonylurea compared with placebo plus sulfonylurea.

Dulaglutide was initially approved in September 2014 as a once-weekly injectable drug to improve glucose in adults with T2D. According to the release, dulaglutide is the first and only GLP-1 receptor agonist with a label that includes its use in combination with basal insulin or mealtime insulin.

Dulaglutide has a boxed warning about potential thyroid tumors, including cancer, and should not be taken by an individual with a familial history of medullary thyroid cancer, Multiple Endocrine Neoplasia syndrome type 2, or an allergy to dulaglutide.