Dulaglutide Approved for Use in Combination With Basal Insulin
The approval is based on trial results which included a total of 300 patients with a mean baseline A1C of 8.4%
The labeling for dulaglutide (Trulicity®, Eli Lilly) has been updated to include use in combination with basal insulin for adults with type 2 diabetes, following approval from the Food and Drug Administration (FDA).
Dulaglutide is a once-weekly glucagon-like peptide-1 (GLP-1) receptor agonist injectable used to improve glycemic control in adults with type 2 diabetes. This approval makes it the first GLP-1 receptor agonist with a label that allows its use in combination with mealtime or basal insulin.
The update was approved by the FDA following a review of results from the AWARD-9 clinical trial, a Phase 3b, placebo-controlled, 28-week study that evaluated the efficacy and safety of once-weekly Trulicity 1.5mg as an add on to titrated insulin glargine compared to placebo as an add-on to titrated insulin glargine.
The trial included a total of 300 patients with a mean baseline A1C of 8.4%.
Results showed that dulaglutide significantly reduced A1C as an add-on to insulin glargine (1.4%) after 28 weeks compared to placebo plus insulin glargine (0.7%).
The most commonly reported adverse events for people taking dulaglutide were gastrointestinal-related and were consistent with prior dulaglutide studies, including nausea (12%) and diarrhea (11.3%).
Trulicity is available in a prefilled pen in 0.75 and 1.5mg doses.
Lilly's Trulicity® (dulaglutide) Label Updated to Include Use in Combination with Basal Insulin for Adults with Type 2 Diabetes [news release]. Indianapolis, IN: Eli Lilly and Company; February 8, 2017. http://www.prnewswire.com/news-releases/lillys-trulicity-dulaglutide-label-updated-to-include-use-in-combination-with-basal-insulin-for-adults-with-type-2-diabetes-300403929.html. Accessed February 10, 2017.