FDA Approves Once-Weekly Dulaglutide for Type 2 Diabetes

Miriam E. Tucker

September 18, 2014

The US Food and Drug Administration (FDA) has approved dulaglutide (Trulicity, Eli Lilly & Co), as a once-weekly injection for the treatment of type 2 diabetes.

A member of the glucagonlike peptide-1 (GLP-1) receptor agonist class, dulaglutide joins liraglutide (Victoza, Novo Nordisk), exenatide (Byetta, AstraZeneca/Bristol-Myers Squibb), and albiglutide (Tanzeum, GlaxoSmithKline), on the US market.

Once-weekly dulaglutide was approved based on 6 clinical trials involving a total of 3342 patients who received the drug. It was studied as a stand-alone therapy and in combination with metformin, sulfonylurea, thiazolidinedione, and prandial insulin.

In one trial the once-weekly dulaglutide was noninferior to daily liraglutide, and in another it topped the oral dipeptidyl peptidase-4 (DPP-4) inhibitor sitagliptin (Januvia, Merck).

The most common side effects observed in patients treated with dulaglutide were nausea, diarrhea, vomiting, abdominal pain, and decreased appetite.

Dulaglutide should not be used to treat people with type 1 diabetes, diabetic ketoacidosis, or severe abdominal or intestinal problems, or as first-line therapy for patients who cannot be managed with diet and exercise.

As with others in its class, dulaglutide's label will include a boxed warning that thyroid C-cell tumors have been observed in rodents but the risk in humans is unknown. The drug should not be used in patients with a personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2.

The FDA is requiring Lilly to conduct the following postmarketing studies for dulaglutide:

•  A clinical trial to evaluate dosing, efficacy, and safety in children.

•  A study to assess potential effects on sexual maturation, reproduction, and central nervous system development and function in immature rats.

•  An MTC case registry of at least 15 years' duration to identify any increase in MTC incidence with the drug.

•  A clinical trial comparing dulaglutide 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 drug's cardiovascular risk profile in patients with high baseline risk for cardiovascular disease.

The FDA approval also comes with a risk evaluation and mitigation strategy (REMS), including a communication plan to inform healthcare professionals about the serious risks associated with the drug.


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