FDA Approves Once-Weekly GLP-1 Agonist for Type 2 Diabetes

Dulaglutide (Trulicity), a once-weekly glucagon-like peptide-1 (GLP-1) receptor agonist, is now approved as an adjunct to diet and exercise in the treatment of type 2 diabetes in adults. The medication is delivered via a single-dose pen that does not require mixing, measuring, or needle attachment.

Safety and Effectiveness Evaluated
The drug’s safety and effectiveness were evaluated in six clinical trials involving 3,342 patients with type 2 diabetes randomized to dulaglutide, according to the U.S. Food and Drug Administration (FDA). The agent has shown efficacy in significantly reducing hemoglobin A1c level when used as monotherapy and in combination with other type 2 diabetes therapies, including metformin, pioglitazone, prandial insulin, sulfonylurea, and thiazolidinedione. The agent has not been studied in combination with basal insulin.

Clinical Trials
In head-to-head clinical studies, dulaglutide was found not inferior to once-daily insulin glargine‎, liraglutide or sitagliptin in metformin-treated patients in reducing A1C levels.

In clinical trials, the most common side effects observed in patients treated with dulaglutide were nausea (12.4% with 0.75 mg and 21.1 with 1.5 mg), diarrhea (8.9% and 12.6%), vomiting (6.0% and 12.7%), abdominal pain (6.5% and 9.4%), and decreased appetite (4.9% and 8.6%). 

Recommended Starting Dose
The recommended starting dose is 0.75 mg, and the agent is scheduled to be available in both 0.75 mg and 1.5 mg single-dose pens later this year, according to the manufacturer Eli Lilly and Company.

Contraindications and Black Box Warning
Dulaglutide should not be used to treat people with type 1 diabetes, diabetic ketoacidosis, or preexisting severe gastrointestinal disease, according to the agent’s prescribing information. Dulaglutide is not recommended as first-line therapy for patients inadequately controlled on diet and exercise. In addition, other antidiabetic therapies should be considered for patients with a history of pancreatitis as dulaglutide has not been studies in patients with pancreatitis.

The prescribing information for dulaglutide contains a Boxed Warning regarding an increased risk for thyroid C-cell tumors based on rodent studies. Currently, it is unknown whether this increased risk also pertains to humans, according to the FDA. The agent is contraindicated in patients with a personal or family history of medullary thyroid carcinoma and in patients with multiple endocrine neoplasia syndrome type 2.

September 29, 2014

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