FDA Approves New Once-Weekly Injectable for Type 2 Diabetes

By Larry Husten

Edited by André Sofair, MD, MPH

The FDA has approved dulaglutide — a once-weekly, injectable, glucagon-like peptide-1 (GLP-1) receptor agonist — to control blood sugar in adults with type 2 diabetes. The drug will be marketed as Trulicity.

Dulaglutide can be given as monotherapy or in combination with other diabetes drugs, including metformin, sulfonylureas, thiazolidinediones, and prandial insulin. It is not indicated for patients with type 1 diabetes, diabetic ketoacidosis, or severe gastrointestinal problems. It should not be used as initial therapy in those whose diabetes cannot be managed with diet and exercise.

Like other GLP-1-receptor agonists, dulaglutide has been linked to thyroid C-cell tumors in rodents. It is unknown whether it can cause these tumors, including medullary thyroid carcinoma (MTC), in humans. Dulaglutide should not be used in patients with a personal or family history of MTC or in patients with multiple endocrine neoplasia syndrome type 2, which may predispose them to MTC.