FDA Approves Trulicity Type 2 Diabetes Treatment, But Requires Further Study

The FDA today approved dulaglutide (Trulicity), a once-weekly injectable therapy indicated to improve blood sugar control in adults with type 2 diabetes.

“Type 2 diabetes is a serious chronic condition that causes blood glucose levels to rise higher than normal,” said Mary Parks, MD, deputy director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research, in a press release. “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 safety and effectiveness of the glucagon-like peptide-1 receptor agonist were evaluated in 6 clinical trials that involved 3342 patients with type 2 diabetes. Across those trials, the patients who received Trulicity observed reductions in their HbA1C levels, indicating improved glycemic control.

Due to serious risks associated with Trulicity, however, the FDA approved the drug with a Risk Evaluation and Mitigation Strategy (REMS). Trulicity has a boxed warning that thyroid C-cell tumors have been observed in rodent studies, though it is unknown whether Trulicity causes the tumors in humans.

Nevertheless, the FDA warned that Trulicity should not be used in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with multiple endocrine neoplasia syndrome type 2, which predisposes patients to MTC. Trulicity should also not be used in patients with type 1 diabetes; those who have diabetic ketoacidosis; those with severe stomach or intestinal problems; or as first-line therapy for those who cannot be managed with diet and exercise, the FDA said.

The FDA is also requiring the drug’s manufacturer, Eli Lilly and Company, to conduct several post-marketing studies on Trulicity, including:

• A trial to evaluate dosing, efficacy, and safety in pediatric patients.
• A study to assess potential effects on sexual maturation, reproduction, and CNS development and function in immature rats.
• An MTC case registry of at least 15 years duration to identify any increase in MTC incidence related to Trulicity.
• A trial comparing Trulicity with insulin glargine (Lantus) on glycemic control in patients with type 2 diabetes and moderate or severe renal impairment.
• A cardiovascular outcomes trial to evaluate the cardiovascular risk of Trulicity in patients with high baseline risk of cardiovascular disease.

In the completed trials that served as the basis for Trulicity’s approval, the most common side effects were nausea, diarrhea, vomiting, abdominal pain, and decreased appetite, the FDA said.