Diabetes Medication Label Updated to Include Drug-Insulin Combo Use

Eli Lilly’s type 2 diabetes drug, Trulicity (dulaglutide), has updated its label, discussing use in combination with basal insulin for adults with type 2 diabetes to achieve greater blood sugar control.

The FDA first approved Trulicity as a diabetes medication in 2014 with a Risk Evaluation and Mitigation Strategy. Trulicity is a once-weekly glucagon-like peptide-1 (GLP-1) receptor antagonist injectable medication that is indicated to improve glucose control in adults with type 2 diabetes in conjunction with diet and exercise. Trulicity also has a boxed warning about potential thyroid tumors, which have been seen in rodent studies.

The label update is based on an FDA review of results from a clinical trial that examined the efficacy and safety of Trulicity 1.5 mg in combination with titrated insulin glargine, with or without metformin, compared to a placebo. The results showed a significantly reduced A1C when Trulicity was used as an add-on to insulin glargine.

“Despite best efforts to manage their A1C, 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 of Global Medical Affairs, Lilly Diabetes, said in a press 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.”

Trulicity is the first GLP-1 receptor agonist with a label that allows its use in combination with mealtime insulin or basal insulin. The product is available in a prefilled pen in 0.75 and 1.5 mg doses.

Reference

Lilly's Trulicity® (dulaglutide) Label Updated to Include Use in Combination with Basal Insulin for Adults with Type 2 Diabetes [news release]. Indianapolis. Eli Lilly’s website. https://investor.lilly.com/releasedetail.cfm?ReleaseID=1010933. Accessed Feb. 8, 2017.