BETHESDA, MD 19 Sep 2014—The glucagon-like peptide (GLP)-1 receptor agonist dulaglutide has been approved for the treatment of type 2 diabetes, FDA and Eli Lilly and Company announced September 18.
Dulaglutide will be available later this year under the brand name Trulicity, Lilly stated.
According to the labeling (PDF) for dulaglutide, the therapy is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.
The drug is administered once weekly as a s.c. injection and can be used alone or in combination with mealtime insulin or other antiglycemic medications, according to the labeling.
Dulaglutide is not a substitute for insulin. And the GLP-1 receptor agonist should not be used as a first-line agent in any patient whose diabetes is not adequately controlled through diet and exercise.
The labeling also recommends against the use of dulaglutide in patients with diabetic ketoacidosis or a history of pancreatitis or severe gastrointestinal problems.
In clinical trials, dulaglutide has been used alone and in combination with metformin, a sulfonylurea, a thiazolidinedione, and prandial insulin but has not been studied in conjunction with basal insulin regimens.
The most common adverse events reported by clinical trial participants treated with dulaglutide were nausea, diarrhea, vomiting, abdominal pain, and decreased appetite.
A boxed warning and FDA-required Medication Guide (PDF) for dulaglutide warn patients and prescribers about the most serious risks associated with the therapy—medullary thyroid cancer and other thyroid tumors. Dulaglutide is contraindicated in patients with a personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2, a rare genetic syndrome.
FDA stated that dulaglutide will be subject to a risk evaluation and mitigation strategy, or REMS, that consists of a communication plan to educate healthcare providers about the serious risks associated with the drug's use.
The recommended dosage of dulaglutide is 0.75 mg administered subcutaneously once weekly, independent of meals, in the abdomen, thigh, or upper arm. The dosage can be increased to 1.5 mg once weekly, the maximum recommended dosage, in patients who need additional glycemic control.
To lessen the risk of hypoglycemia, the labeling advises clinicians to consider reducing the dosage of concomitantly administered insulin secretagogues or prandial insulin when initiating dulaglutide therapy.
Dulaglutide will be supplied in 0.75- and 1.5-mg single dose pens or prefilled syringes in cartons of four each. The devices should be refrigerated at 2–8 °C and never frozen. If necessary, each prefilled pen or syringe can be stored for up to 14 days at room temperature, not to exceed 30°C.