New GLP-1 agonist approved

A new glucagon-like peptide-1 (GLP-1) receptor agonist, dulaglutide (Trulicity), was approved to treat type 2 diabetes, along with diet and exercise, the FDA recently announced.

Safety and effectiveness of this once-weekly subcutaneous injection were evaluated in 6 clinical trials with 3,342 patients with type 2 diabetes. Patients receiving the drug had reductions in HbA1c levels. Dulaglutide has been studied as a stand-alone therapy and in combination with other therapies, including metformin, sulfonylureas, thiazolidinediones, and prandial insulin. It should not be used to treat type 1 diabetes or diabetic ketoacidosis, in patients with severe stomach or intestinal problems, or as first-line therapy.

In clinical trials, the most common side effects were nausea, diarrhea, vomiting, abdominal pain, and decreased appetite. Dulaglutide has a boxed warning that thyroid C-cell tumors have been observed in rodents but it is unknown whether the drug causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans. It should not be used in patients with a personal or family history of MTC or in patients with multiple endocrine neoplasia syndrome type 2. The FDA is requiring several postmarketing studies, including trials in patients with renal impairment and increased cardiovascular risk, according to an FDA press release.