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FDA approves label update for Trulicity to include use in combination with basal insulin
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The FDA has approved a label update for the GLP-1 receptor agonist dulaglutide, allowing for its use in combination with basal insulin for adults with type 2 diabetes, Eli Lilly announced in a press release.
The update makes dulaglutide (Trulicity), the first GLP-1 receptor agonist with a label indication for combination use with mealtime insulin or basal insulin.
"Despite best efforts to manage their [HbA1c], many adults with type 2 diabetes may need to add to or change their treatment plan to help them reach their blood sugar goals," Sherry Martin, MD, vice president, Global Medical Affairs, Lilly Diabetes, said in a statement. "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 FDA review of results from the AWARD-9 clinical 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. Study results showed that dulaglutide 1.5 mg reduced HbA1c as an add-on to insulin glargine by a mean of 1.4% after 28 weeks compared with placebo plus insulin glargine (0.7%).
The label was also updated to include results from the AWARD-8 clinical 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 should not be used by people with type 1 diabetes, people with diabetic ketoacidosis, or people with a history of severe stomach or intestinal problems. It has not been studied in children.
Dulaglutide has a Boxed Warning about potential thyroid tumors, including cancer. It 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.