FDA Approves Once-Weekly Injectable Treatment for Type 2 Diabetes

The US Food and Drug Administration (FDA) today approved Eli Lilly and Company’s Trulicity (dulaglutide), a once-weekly subcutaneous injection to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes.

Trulicity is a glucagon-like peptide-1 (GLP-1) receptor agonist that has been studied as a stand-alone therapy and in combination with other type 2 diabetes therapies (including metformin, sulfonylurea, thiazolidinedione, and prandial insulin) in six clinical trials that enrolled a total of 3,342 patients with type 2 diabetes.

In the trials, patients treated with Trulicity experienced reductions in HbA1c level, indicating improvement in their blood sugar control. The most common side effects observed in trial participants treated with Trulicity were nausea, diarrhea, vomiting, abdominal pain, and decreased appetite.

Trulicity is contraindicated in patients with type 1 diabetes, diabetic ketoacidosis, or severe stomach or intestinal problems. Trulicity should also not be used as first-line therapy for patients with type 2 diabetes who cannot be managed with diet and exercise.

According to the FDA announcement, Trulicity carries a boxed warning that thyroid C-cell tumors have been observed in rodent studies with Trulicity. However, it is unknown whether Trulicity causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans. Trulicity should not be used in patients with a personal or family history of MTC or in patients with multiple endocrine neoplasia syndrome type 2.

Because of the serious risks associated with Trulicity, the FDA approval also requires a Risk Evaluation and Mitigation Strategy (REMS), which consists of a communication plan to inform health care professionals about these risks.

The FDA is also requiring Eli Lilly to conduct several post-marketing studies, including

• A clinical 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;
• A MTC case registry of at least 15 years duration to identify any increase in MTC incidence related to Trulicity
• A clinical trial comparing Trulicity with insulin glargine 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

Mary Parks, MD, deputy director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research, said that “type 2 diabetes is a serious chronic condition that causes blood glucose levels to rise higher than normal. 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.”