FDA approves dulaglutide to treat type 2 diabetes

The FDA today approved dulaglutide as a once-weekly injection for patients with type 2 diabetes to improve glycemic control in conjunction with diet and exercise.

Dulaglutide, a glucagon-like peptide-1 receptor to be known as Trulicity (Eli Lilly), has been studied as a solo treatment and in conjunction with other therapies such as metformin, sulfonylurea and others. In the most recent study published, dulaglutide was shown comparable to liraglutide (Victoza, Novo Nordisk) in controlling HbA1c and hypoglycemia. The most common side effects were nausea, diarrhea, vomiting, abdominal pain and decreased appetite.

“Type 2 diabetes is a serious chronic condition that causes blood glucose levels to rise higher than normal,” Mary Parks, MD, deputy director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research, said in a press release from the FDA. “Trulicity is a new treatment option, which can be used alone or added to existing treatment regimens to control blood sugar levels in the overall management of type 2 diabetes.”

The announcement came with instructions not to use this medication in patients with type 1 diabetes, diabetic ketoacidosis and severe stomach or intestinal complications or as first-line therapy when a patient can be managed through diet and exercise.

The product will carry a black-box warning that thyroid C-cell tumors have been seen in animal studies, but correlation has not been substantiated in humans. Therefore, dulaglutide should not be used in patients with a family history of medullary thyroid carcinoma or those with multiple endocrine neoplasia syndrome type 2.

The FDA requires five post-marketing studies be conducted: a clinical trial evaluating the drug in pediatric patients; a study to assess sexual and central nervous system developments in immature rats; an MTC case registry with at least 15 years of data; a clinical trial to compare this drug with insulin glargine in patients with type 2 diabetes and renal impairment; and a cardiovascular outcomes trial looking at patients with type 2 diabetes and a high baseline risk for CVD.

Additionally, dulaglutide will carry a Risk Evaluation and Mitigation Strategy in order to relay the aforementioned risks to practitioners.

“Type 2 diabetes is a progressive, complex disease, and there continues to be a need for new treatment options to help patients improve their blood glucose levels. As part of our commitment to provide a broad range of products and practical solutions to help make life better for people with diabetes, we’re excited to add this newest treatment option to our comprehensive portfolio,” Enrique Conterno, president of Lilly Diabetes, said in a company statement.

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FDA approves Trulicity to treat type 2 diabetes