FDA Approves Once-weekly Trulicity to Treat Type 2 Diabetes

The U.S. Food and Drug Administration recently approved Trulicity, a once-weekly injectable to treat adults with type 2 diabetes.

Also known as dulaglutide, Trulicity is a glucagon-like peptide-1 (GLP-1) receptor agonist, which helps normalize blood sugar levels by encouraging the release of insulin, which helps the body better use available blood glucose, while suppressing the stimulation of glucose production.

During the six-trial testing phase of the drug, the 3,342 patients with type 2 who received Trulicity in place of a placebo saw improved blood sugar control as well as reduced A1C levels. The main side effects seen during those studies were nausea, vomiting, abdominal pain and loss of appetite.

Trulicity can be used alone or in conjunction with existing type 2 treatments including metformin, sulfonylureas, thiazolidinedione and prandial insulin to help control blood sugar levels, according to Mary Parks, M.D., deputy director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research.

The drug comes with a boxed warning regarding tumors of the thyroid gland that were seen in rodent studies, and should not be used by those with a personal or family history of a type of thyroid cancer known as medullary thyroid carcinoma (MTC) or those with multiple endocrine neoplasia syndrome type 2, which causes tumors in multiple glands of the body and creates a risk for MTC.

The FDA Has recommended several post-marketing studies for Trulicity, which is manufactured by Indianapolis-based Eli Lilly and Company