FDA Updates Trulicity Label

Only GLP-1 receptor agonist for use with mealtime insulin or basal insulin

The FDA has updated the label for once-weekly dulaglutide (Trulicity, Eli Lilly), an injectable glucagon-like peptide-1 (GLP-1) receptor agonist, to include use in combination with basal insulin in adults with type-2 diabetes. Dulaglutide is available in a prefilled pen in 0.75-mg and 1.5-mg doses.

The label update was based on an FDA review of results from the AWARD-9 trial, a phase 3b, randomized, double-blind, placebo-controlled, 28-week study that evaluated the efficacy and safety 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. In the study, dulaglutide 1.5 mg significantly reduced hemoglobin A1c as an add-on to insulin glargine after 28 weeks compared with placebo plus insulin glargine (1.4% vs. 0.7%, respectively).

The label update also included results from the AWARD-8 trial, a phase 3b randomized, double-blind, placebo-controlled, 24-week study that evaluated the efficacy and safety of dulaglutide 1.5 mg as an add-on to sulfonylurea compared with placebo plus sulfonylurea.

Dulaglutide was approved in September 2014 as a once-weekly injectable prescription medication to improve glucose levels in adults with type-2 diabetes, based partly on results from five phase 3 studies of dulaglutide used alone or in combination with other diabetes medications, including metformin, pioglitazone, glimepiride, and insulin lispro. With the new update, dulaglutide is the only GLP-1 receptor agonist with a label that allows its use in combination with mealtime insulin or basal insulin.

Dulaglutide is not recommended as the first medication to treat diabetes. It has not been studied in people who have had pancreatitis. It is not a substitute for insulin. Dulaglutide should not be used by people with type-1 diabetes, by people with diabetic ketoacidosis, or by people with a history of severe stomach or intestinal problems. It has not been studied in children younger than 18 years of age.

The dulaglutide label includes a boxed warning regarding potential thyroid tumors, including cancer. The medication should not be taken by someone with a personal or family history of medullary thyroid cancer; a personal history of multiple endocrine neoplasia syndrome type 2; or an allergy to dulaglutide.

Source: Lilly; February 8, 2017.